Mechanism for automated drug dispensing devices

Abstract

The mechanism for the automated drug dispensing device includes a housing, a dose setting element, a button, a piston rod fixed rotatably to the housing and movable axially, a nut, and a spring. The dose setting element is configured to be grasped by the user of the device to set the dose to be administered by rotating the dose setting element relative to the housing when the mechanism is in the dose setting state, and the rotation of the dose setting element stores energy in the spring. Furthermore, the rotation of the dose setting element moves the nut proximal to the piston rod by a dose distance, the dose distance being proportional to the dose. The mechanism is further configured to switch from the dose setting state to the dose dispensing state when the button is moved axially relative to the housing, for example. The transition to the dose dispensing state causes the nut to move proximal to the nut by coupling the spring to the nut and releasing the energy stored during dose setting. The piston rod is configured to move proximal to the nut by a dose distance when the mechanism is in the dose dispensing state to dispense the dose. Furthermore, the button is configured to remain stationary axially relative to the housing when the dose is being dispensed.

Description

Technical Field

[0001] The present disclosure relates to a mechanism for an automatic pharmaceutical administration device and a pharmaceutical administration device having such a mechanism.

Background Art

[0002] Pharmaceutical administration devices such as injection devices are used to administer liquid pharmaceuticals to patients. Such pharmaceutical administration devices typically include a pharmaceutical container for holding the pharmaceutical and a mechanism configured to discharge a predetermined dose of the pharmaceutical from the container. On the distal side facing away from the administration site, the pharmaceutical container typically includes a movable plunger that seals the pharmaceutical container, and the plunger is moved in the proximal direction toward the injection site to discharge the pharmaceutical from the container. To move the plunger, the mechanism typically includes a piston rod that acts on the plunger by moving the plunger in the proximal direction. The dose to be administered is then defined by the axial movement of the piston rod and the plunger within the pharmaceutical container.

[0003] When configured as an automatic pharmaceutical administration device, the force that causes the axial movement of the plunger is provided entirely by the energy storage of the mechanism, and the dose of the pharmaceutical is automatically administered when the user triggers the mechanism for dose administration. Typically, such a mechanism includes a release element such as a button that is actuated by the user to trigger dose administration.

[0004] Some types of automatic pharmaceutical administration devices provide a dose setting function for preparing the device for an automatic injection by accumulating energy in an energy storage unit and by defining the amount of pharmaceutical to be administered during dose administration. Thereby, such a device can be configured as a fixed dose device that allows setting only a single dose or amount of the pharmaceutical, or as a variable dose device that allows the user to select from a plurality of predetermined doses, for example two or more predetermined doses.

[0005] International Publication No. 2020 / 015980A1 describes, among other things, an automated drug dispensing device having a knob located at the distal end of the device, which is configured to trigger dose setting and dose dispensing. During dose setting, the user of the device rotates the knob. This causes the knob to move distally away from the device housing by a distance proportional to the set dose. Furthermore, the rotation of the knob pulls a torsion spring located within the device.

[0006] To initiate dose dispensing, the user pushes the knob proximally. This releases the spring, thereby driving the dose dispensing. During dose dispensing, the knob returns towards the housing by the same distance it previously moved away from the housing during dose setting.

[0007] Therefore, the device described in International Publication No. 2020 / 015980A1 includes movable components that are accessible to the device user and need to be moved during dose administration. This carries the risk that the user may interfere with these components during dose administration, thereby potentially interfering with drug delivery.

[0008] Furthermore, the device described in International Publication No. 2020 / 015980A1 includes a single actuation member in the form of a knob used for both dose setting and initiating automatic dose administration. This could complicate the use of the device, as it must be avoided that the user may inadvertently trigger dose administration by pressing the knob when attempting to change the dose setting.

[0009] Therefore, the object of this disclosure is to provide a mechanism and a drug administration device for an automated drug administration device that enables user-friendly and safe dose setting and dose administration. [Overview of the Initiative]

[0010] This disclosure provides mechanisms and devices for automated drug dispensing devices. Embodiments are given in the dependent claims, specification and drawings.

[0011] In one embodiment, the disclosure relates to a mechanism for an automated drug dispensing device comprising a housing, a dose setting element, a button, a piston rod fixed rotatably to the housing and movable axially, a nut, and a spring. The dose setting element is configured to be grasped by the user of the device to set the dose to be administered by rotating the dose setting element relative to the housing when the mechanism is in the dose setting state, and the rotation of the dose setting element stores energy in the spring. Furthermore, the rotation of the dose setting element moves the nut proximal to the piston rod by a dose distance, the dose distance being proportional to the dose. The mechanism is further configured to switch from the dose setting state to the dose dispensing state when the button is moved, for example, axially to the housing. The spring is coupled to the nut in the dose dispensing state, causing the nut to automatically move proximal by releasing the energy stored during dose setting. The piston rod is configured to move proximal to the nut by a dose distance to dispense the dose when the mechanism is in the dose dispensing state. Furthermore, the button is configured to remain stationary axially relative to the housing when a dose is being administered.

[0012] The mechanism for the automated drug dispensing device provides a button that does not need to move axially during dose dispensing, thus reducing the risk of the device user interfering with components that move during automated drug dispensing. This provides a user-friendly and safe mechanism.

[0013] The transition to the dose-administering state can be achieved by connecting a spring to the nut, releasing the energy accumulated during dose setting, which causes the nut to move automatically in the proximal direction.

[0014] In this mechanism, the button can be configured to remain axially stationary relative to the housing while the piston rod moves proximal to administer the dose.

[0015] In this mechanism, drug administration does not necessarily require axial movement of the button, at least after the mechanism has transitioned to the dose-administration state. However, generally, the button can be axially movable relative to the housing. For example, the button can be configured to move axially when an autoinjector is triggered and / or when an autoinjector is interrupted. Furthermore, dose administration can begin as soon as the button is still in its fully triggered position and / or continue while the autoinjector is interrupted as the button begins to move away from its fully triggered position.

[0016] Therefore, configuring the button to remain axially stationary relative to the housing when the piston rod moves proximal to administer a dose includes configuring the button to remain axially stationary relative to the housing for at least a portion of the proximal movement of the piston rod during dose administration.

[0017] A mechanism having a nut that moves distally to the piston rod during dose setting and proximal to the piston rod during dose administration provides a mechanically simple and compact operating arrangement for the piston rod.

[0018] In addition to the button, the dose setting element can also be configured to remain axially stationary relative to the housing when the piston rod moves proximal to administer the dose.

[0019] For example, the dose setting element may be configured to remain axially stationary relative to the housing while the piston rod moves proximal to administer the dose.

[0020] The dose setting element may include a gripping surface configured to be grasped by the user. The gripping surface may be the outer surface of the dose setting element. Furthermore, the gripping surface may be configured as a structured surface to increase friction when gripping the dose setting element. For example, the gripping surface may have grooves and / or ridges. The dose setting element may have a cylindrical shape. The gripping surface may be the outer cylindrical surface and / or outer peripheral surface of the dose setting element.

[0021] The dose setting element can be configured to rotate around the longitudinal axis of the mechanism during dose setting.

[0022] The mechanism can be configured to provide sufficient force from a spring during dose dispensing to automatically administer the set dose. Such a mechanism does not rely on the force provided by the user of the mechanism to advance the piston rod. For example, the mechanism can be configured to prevent the force applied by the user to a button during dose dispensing from being transmitted to the piston rod.

[0023] The spring can be indirectly connected to the nut in a dose-dispensing state, for example, by one or more intermediate members. These intermediate members can be configured to convert the torque provided by the spring into axial movement of the nut. For example, one or more intermediate members can be configured to push the nut axially during dose dispensing. The intermediate members may be formed by the driver of the mechanism.

[0024] The housing can form an outer housing or outer enclosure of the mechanism. It may consist of a single component or multiple components permanently fixed to one another. The housing can enclose at least a portion of the mechanism.

[0025] The housing may have an elongated shape extending along the longitudinal axis. The housing may also have a substantially cylindrical shape. The piston rod may also extend along the longitudinal axis.

[0026] The mechanism can include a dosage definition mechanism that enables a user of the device to set at least one dosage of the medicine for administration. For example, the dosage definition mechanism can be configured to allow only a single predetermined dosage to be set. Alternatively, the dosage definition mechanism may also be configured to allow a plurality of different predetermined dosages, such as two or more different dosages, to be set by the user.

[0027] The mechanism can be configured as a disposable mechanism that allows the dosage to be set only once and then prevents the user from setting and administering further dosages. The mechanism may also be configured as a multi-purpose mechanism that allows the dosage for administration to be repeatedly set.

[0028] The housing can be configured to connect to a medicine container that houses the medicine to be administered. For example, the housing can have a connector that enables a separate container holder that holds the medicine container to be attached to the housing. The connector may be configured as a form fit, such as a snap-fit connector or a threaded connector, or as an adhesive bond, such as a welded or glued connection. Alternatively, the housing can also be connected to the medicine container by including a container holder that is integrally formed with a housing section that includes other components of the mechanism, such as a piston rod guide.

[0029] The dosage administration mechanism can include a bearing configured to directly contact the plunger of the attached medicine container. The bearing can be located on the piston rod. Thereby, the bearing can be integrally formed with the piston rod. Alternatively, the bearing may be configured as a separate component, such as a disk, located between the piston rod and the plunger. For example, the bearing can be attached to the piston rod.

[0030] The mechanism can be configured as a disposable mechanism that is discarded after discharging the last dose from the pharmaceutical container attached to the mechanism. Alternatively, the mechanism may also be configured as a reusable mechanism that allows attachment of a new pharmaceutical container after discharging the last dose from the previous container.

[0031] The dose setting element and the button can form elements of the operating unit of the mechanism. The dose setting element and the button can be arranged adjacent to each other. For example, the dose setting element and the button can be located at the distal end of the mechanism. The button can terminate the mechanism at its distal end.

[0032] The button may be axially movable relative to the housing. Thereby, the button can be biased in the distal direction relative to the housing. For example, the mechanism can include a biasing element, such as a spring, e.g., a compression spring, that biases the button in the distal direction relative to the housing.

[0033] In some embodiments, the dose setting element and the button are fixed relative to each other during dose setting and dose administration. This provides a simple and compact structure for the button and the dose setting element. For example, the button and the dose setting element can be integrally formed. Alternatively, the button and the dose setting element can be configured as separate components that are fixed to each other directly or via one or more intermediate components.

[0034] In other embodiments, the dose setting element and the button are movable relative to each other. This makes it possible to clearly separate the rotation of the dose setting element for setting the dose during dose setting from the movement of the button for transitioning the mechanism to the dose administration state. For example, the button can be configured to move axially relative to the dose setting element when transitioning from the dose setting state to the dose administration state.

[0035] In some embodiments, the button is axially movable relative to the dose setting element and fixed in the rotational direction relative to the dose setting element. The button can be configured to follow the rotation of the dose setting element during dose setting, and at the same time, to move axially relative to the dose setting element to transition the mechanism to the dose-administering state. Following the rotation of the dose setting element during dose setting facilitates dose setting, for example, in embodiments where the dose setting element and the button are located adjacent to each other.

[0036] In some embodiments, the dose setting element is fixed in a rotational direction relative to the housing when a dose is being administered. This reduces the number of moving external parts of the mechanism during dose administration and thus provides a user-friendly mechanism. The mechanism may include, for example, a clutch that fixes the dose setting element in a rotational direction to the housing during dose administration and releases the dose setting element in a rotational direction from the housing during dose setting. The clutch may be configured to close when the button moves, for example, when the button moves axially.

[0037] In some embodiments, the dose setting element is fixed axially to the housing during dose setting and dose administration. This reduces the number of degrees of freedom of movement for such dose setting element, thus providing a user-friendly design.

[0038] In some embodiments, the button is configured to remain axially stationary relative to the housing when the piston rod moves proximal to dispense a dose. This reduces the risk of the device user interfering with components that move during automated drug dispensing, providing a user-friendly and safe mechanism.

[0039] The administration of the drug may not require axial movement of the button after the mechanism has transitioned to the dose-administration state. Furthermore, dose administration can begin even while the button is still in its fully triggered position, and / or dose administration can continue while the button is beginning to return from its fully triggered position, for example, to interrupt the autoinjector.

[0040] Therefore, configuring the button to remain axially stationary relative to the housing when the piston rod moves proximal to administer a dose includes configuring the button to remain axially stationary relative to the housing for at least a portion of the proximal movement of the piston rod during dose administration.

[0041] According to one embodiment, the mechanism further includes a drug delivery member configured to rotate relative to the housing during dose setting and during dose delivery, and to remain stationary axially relative to the housing during dose delivery. Compared to a drug delivery member configured to move axially during dose delivery, a drug delivery member fixed axially during dose delivery provides a more compact structure for the mechanism.

[0042] Buttons and / or dose-setting elements can be coupled to the housing via a dispensing member. For example, buttons and / or dose-setting elements can be axially coupled to the housing via a dispensing member. The dispensing member can then restrict the axial movement of buttons and / or dose-setting elements relative to the housing.

[0043] The dispensing component may include a dose sleeve that at least partially surrounds the piston rod and / or nut.

[0044] In some embodiments, the drug delivery member comprises a first part and a second part, The first part is axially movable relative to the second part and fixed in the rotational direction. This makes it possible to axially fix the first and second parts to different components of a mechanism that is axially movable relative to each other.

[0045] Both the first and second parts are configured to remain axially stationary relative to the housing during dose administration, and therefore the drug delivery member as a whole remains axially stationary during dose administration. Either the first or second part may be configured to move axially relative to the housing when the mechanism transitions between a dose setting state and a dose administration state. The first and second parts may be configured to move axially relative to each other when the mechanism transitions between a dose setting state and a dose administration state.

[0046] In some embodiments, the first portion is fixed axially to a button and / or the second portion is fixed axially to a housing. The first portion may be a coupling member that connects a drug delivery member to a dose setting element during dose setting. Additionally or alternatively, the first portion may be a carrier containing elements of a dose-defining mechanism, such as a dose stop unit or one of counter elements for engaging with a dose stop unit. The second portion may be a dose sleeve.

[0047] In some embodiments, the rotational position of the drug delivery member defines the dose administered in the dose-administering state. For example, each rotational position of the drug delivery member can uniquely define the dose to be administered. The drug delivery member can then be configured to perform less than one rotation during dose setting. The rotational position can be defined relative to the housing of the mechanism.

[0048] In some embodiments, the rotational position of the drug delivery member defines the dose to be administered in the dose-administering state, and the first part includes one of the dose-stopping and counter elements of the dose-defining mechanism. The dose-defining mechanism can then act between the drug delivery member and the housing of the mechanism.

[0049] According to one embodiment, the drug dispensing member is configured to remain axially stationary relative to the housing while energy is being stored in the spring during dose setting. Such a drug dispensing member provides a compact structure for the mechanism.

[0050] According to one embodiment, a drug dispensing member is coupled between a spring and a dose setting element during dose setting to transmit energy from the dose setting element to the spring. For example, the drug dispensing member can be fixed in a rotational direction relative to the dose setting element during dose setting. Torque supplied to the dose setting element by the user during dose setting can be transmitted to the spring via the drug dispensing member.

[0051] According to one embodiment, the medication dispensing member includes a label that visually indicates the dose setting. The label then rotates relative to the housing during dose setting and dose administration. This makes it possible to reset the display of the set dose during dose administration.

[0052] The label can be configured to be visible from the outside of the housing when the dosage is set. For example, the label can be viewed through a window provided in the housing. The label can be provided on a component of the medication dispenser that is fixed axially to the housing, such as a dosage sleeve.

[0053] In some embodiments, the dose setting element is configured to remain axially stationary relative to the drug delivery member during dose administration. Additionally or alternatively, the dose setting element may be configured to remain axially stationary relative to the drug delivery member during dose setting.

[0054] According to one embodiment, the mechanism further includes a blocker that acts between the button and the housing, preventing the button from moving distally in the axial direction relative to the housing. Such a blocker can prevent the button from detaching from the housing. Additionally or alternatively, the blocker may be configured to prevent axial movement of the dose-setting element distally to the housing.

[0055] According to one embodiment, the blocker acts between the dispensing member and the housing. This secures the button and / or dose setting element to the housing via the dispensing member. The blocker can act directly between the housing and the dispensing member so that the dispensing member engages with the housing via the blocker. Alternatively, the blocker can act via one or more intermediate members between the housing and the dispensing member.

[0056] According to one embodiment, a blocker is provided on one of the housing and the drug dispensing member and engages with the other of the housing and the drug dispensing member. This provides a blocker that acts directly between the housing and the drug dispensing member. The blocker can be fixed to one of the housing and the drug dispensing member.

[0057] In some embodiments, the blocker is configured as an axial stopper. This precisely defines the axial position limits of the button and / or dose setting element in the distal direction.

[0058] Generally, an axial stopper may include two stopping surfaces that move toward each other along the longitudinal axis of the mechanism and engage with each other to stop further axial movement. The stopping surfaces may be oriented parallel to each other.

[0059] Each stopping surface may be oriented essentially perpendicular, such as perpendicular to the longitudinal axis of the mechanism, and essentially parallel, such as parallel to a radial plane oriented perpendicular to the longitudinal axis. Alternatively, each stopping surface may be inclined with respect to the radial plane. Such inclination can provide an undercut, which may be configured to press the stopping surfaces against each other when engaged.

[0060] According to one embodiment, the blocker is configured as a unidirectional blocker, which allows relative axial movement between the housing and the counter member in a first direction and prevents relative axial movement between the housing and the counter member in a second direction opposite to the first direction. This facilitates the assembly of the mechanism because the housing and the counter member can be moved relative to each other in the first direction during assembly, and the housing and the counter member can be constrained relative to each other in the second direction after assembly.

[0061] For example, a blocker can allow the counter member to move axially proximal to the housing and prevent its distal axial movement relative to the housing. This makes it possible to insert the counter member into the housing from the distal end during assembly.

[0062] According to one embodiment, the blocker is configured as a flexible element that snaps into a blocking position when the counter member is assembled to the housing. This provides simple assembly of the mechanism.

[0063] For example, a blocker can be configured to flex during the assembly of the counter member to the housing and snap into a locking position when the counter member is positioned relative to the housing. In such a configuration, the blocker can be fixed to the housing and one of the counter members during assembly.

[0064] In other embodiments, the blocker may be configured as a separate element that is attached to and / or fixed to one of the housing and the counter member after the counter member has been assembled to the housing. The blocker may be configured to be attached to and / or fixed to one of the housing and the counter member by a morph-fit such as a screw connection or a snap fit. Exemplaryly, the blocker may be configured to be fixed and / or attached to the housing during assembly.

[0065] According to one embodiment, the counter member is part of the dispensing member. This makes it possible to fix and / or attach the blocker to the housing during assembly.

[0066] In other embodiments, the counter member is part of the housing. This allows the blocker to be fixed and / or attached to the counter member.

[0067] According to one embodiment, the mechanism includes a stopper for restricting the proximal movement of the button during dose administration. This precisely defines the position of the button after the mechanism transitions to the dose administration state. The button may be configured to interact with the stopper directly or through one or more intermediate members. The stopper can restrict the proximal movement of the button relative to the housing.

[0068] The stopper may include a first stopper portion and a second stopper portion. The first and second stopper portions may be configured to move toward each other during proximal movement of the button and to engage with each other during dose administration to restrict further proximal movement of the button. Furthermore, the first and second stopper portions may be configured to move away from each other during distal movement of the button.

[0069] According to one embodiment, the dispensing member is coupled between a stopper and a housing. The stopper then restricts the proximal movement of the button relative to the dispensing member. In addition, the dispensing member can restrict the proximal movement of the button relative to the housing. For example, the dispensing member can be fixed axially to the housing.

[0070] In some embodiments, the proximal force exerted on the button during dose administration may be transmitted to the housing only through components that remain stationary during dose administration.

[0071] According to one embodiment, the stopper is provided on the housing, such as on the inner surface of the housing. This allows the housing to directly absorb the proximal force applied to the button, and thus direct this force away from the components moving during dose dispensing. This can reduce friction within the mechanism.

[0072] According to one embodiment, the stopper acts between the housing and a housing connector fixed axially to the button. For example, the first stopper may be fixed to the housing, and the second stopper may be fixed to the housing connector. The housing and the housing connector can engage with each other via the stopper.

[0073] The button may be rotatably movable relative to the housing connector. The housing connector may be configured, for example, as a dose selector for the mechanism.

[0074] In other embodiments, the stop mechanism can operate between the dose setting element and a button. This provides a simple structure for the stop mechanism. In these embodiments, the button can be axially movable relative to the dose setting element. The dose setting element can be axially constrained, for example, axially fixed, relative to the housing.

[0075] Next, the first stop portion can be fixed to the dose setting element, and the second stop portion can be fixed to a button.

[0076] According to one embodiment, the stopper is configured as an axial stopper. This precisely defines the limit of the axial position of the button in the distal direction. The axial stopper may be configured as disclosed in relation to the axial stopper of the blocker described above.

[0077] In some embodiments, the mechanism further includes a retainer for preventing the button and / or dose setting element from coming out of the housing, the retainer comprising a first retainer element and a second retainer element, the first retainer element and the second retainer element being configured to engage with each other to prevent the button and / or dose setting element from coming out of the housing.

[0078] In some embodiments, the retainer acts between the dispensing member on the one hand and the button and / or dose setting element on the other hand. For example, the retainer can act between the housing on the one hand and the button and / or dose setting element on the other hand via the dispensing member.

[0079] In some embodiments, the dose setting element is fixed axially to the housing, and a retainer is configured to prevent the button from coming off the housing, with the retainer acting between the dose setting element and the button.

[0080] In some embodiments, the first retainer element and the second retainer element are configured to move away from each other to allow axial movement of the button and / or dose setting element in the proximal direction relative to the housing.

[0081] In some embodiments, the retainer is configured as an axial stopper. This allows the button and / or dose setting element to be firmly secured to the housing. The axial stopper can be configured as disclosed above in relation to the axial stopper of the blocker.

[0082] In some embodiments, the mechanism further includes a driver coupled between a spring and a nut to transfer energy stored in the spring to the nut when the mechanism is in a dose-administering state. Furthermore, the driver is configured to move distally when the mechanism is in a dose-setting state and proximal when the mechanism is in a dose-administering state.

[0083] The driver can be configured to engage with the knob and transmit the energy stored in the spring in a dose-administered state. For example, the driver can be configured to push the nut axially.

[0084] In some embodiments, the spring is coupled between the driver and the housing. The spring can then be deformed by moving the driver, for example, by moving the driver in a rotational direction during dose setting. Furthermore, the spring can be released by moving the driver, for example, by moving the driver in a rotational direction relative to the housing. The driver can then transmit the energy stored in the spring during dose setting to the nut and piston rod. The spring may be coupled directly to the driver and / or directly to the housing. This provides a compact structure for the mechanism.

[0085] In some embodiments, the driver is rotationally driven by a spring during dose administration. In this case, the driver can be configured to convert rotational movement into axial movement, for example, via a screw connection.

[0086] In some embodiments, a driver is coupled between the spring and the dose-setting element during dose setting to transfer energy from the dose-setting element to the spring. The driver is then configured to couple the spring to the mechanism both during dose setting and dose administration. For example, the driver can be permanently coupled to one end of the spring both during dose setting and dose administration.

[0087] In some embodiments, the driver is fixed in the rotational direction relative to the nut when the mechanism is in the dose setting state, and is movable in the rotational direction relative to the nut when the mechanism is in the dose dispensing state. The driver, which rotates with the nut, allows for simultaneous axial movement of the nut and the driver, for example, via their respective screw connections to the housing. Then, by disengaging the nut from the driver in the rotational direction during dose dispensing, it may be possible to axially lock the nut to the piston rod.

[0088] In some embodiments, the driver is fixed in the rotational direction relative to the dose setting element when the mechanism is in the dose setting state, and is movable in the rotational direction relative to the dose setting element when the mechanism is in the dose administration state. This detaches the dose setting element from the driver during dose administration so that the dose setting element can remain stationary in the rotational direction during dose administration.

[0089] In some embodiments, the driver is rotatably movable relative to the housing during dose setting and dose administration. The driver can then rotatably couple the spring to other moving parts of the mechanism, both during dose setting and dose administration.

[0090] In some embodiments, the mechanism includes a drive thread that connects the driver to the housing, and the drive thread converts torque provided by a spring into axial movement of the driver. For example, the driver can screw-engage to the housing via the drive thread.

[0091] In some embodiments, the driver is coupled between the nut and the dispensing member. For example, the driver engages with the dispensing member. This engagement with the dispensing member allows, for example, the driver to be fixed to the dispensing member in a rotational direction.

[0092] In some embodiments, the driver is fixed to the dispensing member in the rotational direction and / or movable in the axial direction. For example, the driver can be connected to the dispensing member by a rotational locking mechanism such as a spline connection. The driver can engage directly with the dispensing member. This can be directly engaged with a second part of the dispensing member that is fixed to the housing in the axial direction, such as a dosage sleeve.

[0093] In some embodiments, the mechanism further includes a dose-defining mechanism that acts between the dose-setting element and the housing during dose setting. Thus, the dose-defining mechanism has at least one dose-stop and counter element, the counter element configured to rotate relative to the dose-stop when the dose-setting element rotates during dose setting, and the counter element configured to engage with the dose-stop when the dose is set. The dose-defining mechanism can define the rotational position of the dose-setting element relative to the housing corresponding to a configurable dose. For each configurable dose, the dose-defining mechanism may include a separate dose-stop.

[0094] The dose-defining mechanism may include a single dose-stop unit or two or more dose-stop units.

[0095] The counter element can be configured as a flexible element that snaps onto the dose stop section when the dose is set. For example, the counter element can be configured as a flexible projection of a component of the mechanism. The counter element can be formed integrally with, for example, a component of the mechanism to which the counter element is fixed.

[0096] In some embodiments, the engagement between the counter element and the dose stop unit prevents the spring from releasing the energy stored during the rotation of the dose setting element. This allows the dose defining mechanism to provide a latching function that keeps the spring taut until the dose is administered by transitioning the mechanism from the dose setting state to the dose administration state.

[0097] In some embodiments, the counter element is configured to disengage from the dose stop when the mechanism transitions from the dose setting state to the dose administration state. This prevents the dose defining mechanism from interfering with the administration of the set dose. Furthermore, it may allow the spring to release the energy accumulated during rotation in dose setting. In embodiments with two or more dose stop units, the counter element may be configured to disengage from all dose stop units when the mechanism transitions to the dose administration state. This allows the counter element to rotate during dose administration and return to its initial position without interfering with the dose stop units. The initial position may correspond to a zero dose position where no dose is set.

[0098] For example, the counter element may be configured to disengage from the dose stop unit by moving axially relative to the dose stop unit.

[0099] In some embodiments, one of the dose stop unit and the counter element, for example, the dose stop unit, is fixed to the housing in a rotational direction. Then, one of the dose stop unit and the counter element can be made axially movable relative to the dose setting element.

[0100] In some embodiments, one of the dose stop unit and the counter element, for example, the dose stop unit, is fixed axially to the button. This allows one of the dose stop unit and the counter element to move together with the button when the mechanism transitions from the dose setting state to the dose administration state. Then, one of the dose stop unit and the counter element can be disengaged from the other by this movement. For example, one of the dose stop unit and the counter element can be guided linearly within the housing.

[0101] In other embodiments, one of the dose stop unit and the counter element is fixed axially to the housing. The other of the dose stop unit and the counter element can be made axially movable relative to the housing, for example by moving a button axially.

[0102] In some embodiments, one of the dose stop unit and the counter element is fixed to the outer housing of the mechanism. The outer housing can be fixed to a connection for coupling a pharmaceutical container to the mechanism. Alternatively, the outer housing may be movable relative to the connection, for example, axially. For example, the outer housing can be a housing connector, for example, a housing connector that engages with the housing via a stop unit during relative axial movement between housings within the housing connector.

[0103] The dose definition mechanism can also operate between the drug delivery member and the housing. It can then define the rotational position of the drug delivery member relative to the housing corresponding to a configurable dose.

[0104] In some embodiments, the other of the dose stop unit and the counter element, for example, the counter element, is fixed to the drug dispensing member in a rotational direction. For example, the other of the dose stop unit and the counter element can be permanently fixed to the drug dispensing member in a rotational direction. The other of the dose stop unit and the counter element can further be fixed axially to the drug dispensing member, such as a first portion of the drug dispensing member that is movable relative to the housing.

[0105] The other of the dose-stopping unit and the counter element can be fixed axially to the housing. For example, the other of the dose-stopping unit and the counter element can be provided in one embodiment of a drug dispensing member that includes a single part fixed axially to the housing.

[0106] In some embodiments, the other of the dose stop unit and the counter element, for example the counter element, is axially movable relative to the button. Then, one of the dose stop unit and the counter element, for example the dose stop unit, can be fixed axially relative to the button. This makes it possible to disengage the dose stop unit from the counter element by moving the button relative to the housing.

[0107] In some embodiments, the other of the dose-stopping unit and the counter element, for example the counter element, is axially movable relative to the housing. In embodiments of a drug dispensing member having a first part that is axially movable relative to a second part, the other of the dose-stopping unit and the counter element can be fixed to the first part of the drug dispensing member. For example, the other of the dose-stopping unit and the counter element can be formed on the drug dispensing member, for example, on the first part of the drug dispensing member.

[0108] In some embodiments, the dose stop unit and the other of the counter element are fixed axially to the button. One of the dose stop unit and the counter element, for example, the dose stop unit, may be movable axially relative to the button. This allows the dose stop unit to be disengaged from the counter element by moving the button relative to the housing.

[0109] In some embodiments, the mechanism includes a blocking mechanism having a first element and a second element, the first element engaging with the second element when the button is released during dose administration to prevent the mechanism from transitioning from a dose administration state to a dose setting state. This maintains dose administration even if the user releases the button during dose administration. The blocking mechanism can prevent distal movement of the button against a biasing force that biases the button distally.

[0110] The blocking mechanism can be configured to disengage the first element from the second element at the zero-dose position where the set dose has been completely administered. This allows the mechanism to return to the dose-setting state, and thus allows subsequent doses to be set after the previous drug administration has been completed.

[0111] In some embodiments, the first element rotates in a first direction relative to the second element during dose setting and rotates in a second direction opposite to the first direction during dose administration. The relative movement between the first and second elements can result in the first and second elements being in relative positions that prevent mutual engagement at the end of dose administration and / or when the dose is set.

[0112] In some embodiments, the first element is configured as a circumferential rib extending longitudinally around the axis of the housing, and the second element is configured as a stop or counter element that moves along the circumferential rib during dose administration.

[0113] In some embodiments, the second element passes through the first element when the button is released at the end of dose administration. For example, the second element may pass through an opening in the first element. The second element can rotate at the end of dose administration to align with the opening.

[0114] In some embodiments, a second element passes through the first element during the transition of the mechanism from a dose-setting state to a dose-administration state. For example, the second element may pass through an opening within the first element. The second element can rotate to align with the opening when the dose is set.

[0115] In some embodiments, a second element passes through an opening in the first element when the mechanism transitions from a dose setting state to a dose administration state. Such an opening prevents obstruction and thus allows axial movement of the button to initiate dose administration.

[0116] In some embodiments, the first element includes a recessed section in the opening, and the second element, after passing through the opening during the transition of the mechanism from a dose-setting state to a dose-administering state, engages with the recessed section when the button is released, and the engagement of the second element with the recessed section prevents the mechanism from transitioning back to the dose-setting state. The recessed section may form a one-way passage for the second element, allowing movement of the second element relative to the first element in a first direction and preventing movement in a second direction opposite to the first direction.

[0117] The first element may have multiple openings. Each opening may have a recessed section. This prevents the second element from passing through the openings in the dose-administering state. For example, the second element may pass along at least one of the openings, such as along multiple openings, during dose administration. The recessed section then prevents the mechanism from transitioning to the dose-setting state at each opening.

[0118] The recessed section may have a chamfered edge that flexes the second element during passage in the first direction. In this case, the recessed section may still interfere with the second element when moving in the second direction opposite to the first direction. When moving in the first direction, the second element can engage with the chamfered edge at a shallow angle. Furthermore, when moving in the second direction, the second element can engage with the recessed section at a steeper angle than the shallow angle.

[0119] In some embodiments, the first element of the blocking mechanism and one of the dose-stopping and counter elements, for example, the dose-stopping element, are fixed to the same member of the mechanism. Furthermore, the second element of the blocking mechanism and the other of the dose-stopping and counter elements, for example, the counter element, are fixed to the same further member of the mechanism. This allows for precise alignment of the elements of the blocking mechanism and the elements of the dose-defining mechanism, thereby increasing the reliability of the mechanism.

[0120] A first element of the blocking mechanism and a component of the mechanism including one of the dose stop unit and the counter element may, for example, be a dose selector of the mechanism. A second element of the blocking mechanism and a further component of the mechanism including the other of the dose stop unit and the counter element may, for example, be a carrier that is rotationally movable relative to the dose selector. The carrier may, for example, be part of a drug dispensing member.

[0121] The dose selector can be at least partially located within the outer housing of the mechanism. The dose selector can be configured to protrude from the outer housing. In other embodiments, the dose selector can be fully located within the outer housing.

[0122] In some embodiments, one of the first and second elements of the blocking mechanism, as well as one of the dose-stopping and counter elements, are formed by a single element. For example, the second element of the blocking mechanism and the counter element of the dose-defining mechanism can be formed by a single element. This facilitates the alignment of the components of the blocking mechanism with respect to the components of the dose-defining mechanism.

[0123] A single element may be a flexible element configured to snap onto the dose stop when rotated relative to the dose stop. Furthermore, a single element may be configured to snap into a recessed section provided on the first element of the blocking mechanism.

[0124] In some embodiments, the mechanism includes a maximum dose mechanism that prevents further rotation of the dose setting element when the dial is set beyond the maximum dose setting, the maximum dose mechanism including a maximum dose stop and a blocking section, the blocking section being configured to engage with the maximum dose stop when the dial is set beyond the maximum dose setting, this provides a clear rotation end position for the dose setting element. The maximum dose stop section can also absorb torque provided by the user and direct the torque towards the mechanism's housing.

[0125] The blocking unit can engage with the maximum dose stop unit just at the maximum dose setting. In other embodiments, the blocking unit can engage with the maximum dose stop unit only after the dial setting has exceeded the maximum dose setting by a predetermined amount.

[0126] The blocking section can be configured as a hard stop that is firmly connected, such as by being integrally formed with the components of the mechanism. Similarly, the maximum dose stopping section can be configured as such a hard stop.

[0127] In some embodiments, the maximum dose stop and the block are configured to rotate relative to each other during dose setting. For example, one of the maximum dose stop and the block, e.g., the maximum dose stop, can be fixed in a rotational direction relative to the housing during dose setting, and the other of the maximum dose stop and the block, e.g., the block, can be fixed in a rotational direction relative to the dose setting element during dose setting. The other of the maximum dose stop and the block can be made rotatably movable relative to the dose setting element during dose administration.

[0128] In some embodiments, the maximum dose stop is configured as a radial stop, and the blocking section is configured to rotate relative to the maximum dose stop when the dial is set beyond the maximum dose. Such a radial stop section provides a distinct rotational position where the blocking section and the maximum dose stop engage.

[0129] The maximum dose stop and blocking sections may include engaging surfaces that engage with each other. The engaging surfaces may be oriented essentially perpendicularly, such as perpendicular to the circumferential direction around the longitudinal axis of the mechanism.

[0130] In some embodiments, one of the maximum dose stop unit and the block unit, for example, the maximum dose stop unit, is fixed to the housing in a rotational direction. One of the maximum dose stop unit and the block unit can be permanently fixed to the housing in a rotational direction both during dose setting and during dose administration.

[0131] In some embodiments, one of the maximum dose stop and the block unit is fixed to the outer housing of the mechanism. The outer housing can be configured, for example, as a housing connector located between the dose setting element and the device housing. Additionally or alternatively, the outer housing can be configured as a dose selector.

[0132] In some embodiments, the other of the maximum dose stop and block, for example the block, is fixed to the drug delivery member in a rotational direction. The other of the maximum dose stop and block then rotates relative to the housing both during dose setting and dose delivery. This makes it possible to reset the maximum dose mechanism during dose delivery. In embodiments that define a set dose at the rotational position of the drug delivery member, the maximum dose position at which the maximum dose stop and block engage with each other is precisely defined by fixing one of the maximum dose stop and block to the drug delivery member in a rotational direction.

[0133] In some embodiments, the other of the maximum dose stop unit and the blocking unit is fixed to a coupling member that rotates the drug delivery member to the dose setting element during dose setting.

[0134] In some embodiments, one of the dose-stopping and counter elements, for example, the dose-stopping unit, and one of the maximum dose-stopping and blocking units, for example, the maximum dose-stopping unit, are fixed to the same member of the mechanism. This makes it possible to precisely define the relative positions of the components of the dose-defining mechanism with respect to the components of the maximum dose mechanism. The member of the mechanism may be, for example, a dose selector.

[0135] In some embodiments, the dose stop unit and the other of the counter elements, such as a counter element, and the other of the maximum dose stop unit and the other of the blocking unit, such as a blocking unit, are fixed to the same further member of the mechanism. This also allows for precise definition of the relative positions of the components of the dose definition mechanism with respect to the components of the maximum dose mechanism. The further member may be, for example, a carrier that is rotationally movable with respect to the dose selector.

[0136] In some embodiments, the mechanism includes a zero-dose mechanism that prevents further axial movement of the nut at the end of dose administration, the zero-dose mechanism including a zero-dose stop and a further stop, the further stop being configured to engage with the zero-dose stop at the end of dose administration. This provides a clear end position for the piston rod at the end of dose administration and thus contributes to precisely defining the amount of pharmacokinetic drug administered.

[0137] Further blocking mechanisms can be configured as, for example, integrally formed hard stops that are firmly connected to the components of the mechanism. Similarly, zero-dose stopping mechanisms can be configured as such hard stops.

[0138] In some embodiments, the zero-dose stop and the further block are configured to rotate relative to each other during dose administration. For example, one of the zero-dose stop and the further block, e.g., the zero-dose stop, can be fixed in a rotational direction relative to the housing during dose setting, and the other of the zero-dose stop and the further block, e.g., the further block, can be fixed in a rotational direction relative to the dose setting element during dose setting. The other of the zero-dose stop and the further block can be made rotatably movable relative to the dose setting element during dose administration.

[0139] In some embodiments, the zero-dose stop is configured as a radial stop, and a further stop is configured to rotate relative to the zero-dose stop at the end of dose administration. Such a radial stop provides a distinct rotational position where the further stop and the zero-dose stop engage with each other.

[0140] The zero-dose stop and further blocking sections may include engaging surfaces that engage with each other. The engaging surfaces may be oriented essentially perpendicularly, such as perpendicular to the circumferential direction around the longitudinal axis of the mechanism.

[0141] In some embodiments, one of the zero-dose stop unit and the further block unit, for example, the zero-dose stop unit, is fixed to the housing in a rotational direction. The zero-dose stop unit and the further block unit can be permanently fixed to the housing in a rotational direction both during dose setting and during dose administration.

[0142] In some embodiments, one of the zero-dose stop unit and / or further blocking unit is fixed to the outer housing of the mechanism. The outer housing can be configured, for example, as a housing connector located between the dose setting element and the device housing. Additionally or alternatively, the outer housing can be configured as a dose selector.

[0143] In some embodiments, the zero-dose stop and the other of the further blockers are fixed to the drug delivery member in a rotational direction. The zero-dose stop and the other of the further blockers then rotate relative to the housing both during dose setting and dose administration. This makes it possible to reset the zero-dose mechanism during dose setting. In embodiments that define a set dose at which the rotational position of the drug delivery member is defined, the zero-dose position at which the zero-dose stop and the further blockers engage with each other is precisely defined by fixing one of the zero-dose stop and the further blockers to the drug delivery member in a rotational direction.

[0144] In some embodiments, the other of the zero-dose stop unit and the further blocking unit is fixed to a coupling member that rotates the drug delivery member to the dose setting member during dose setting.

[0145] In some embodiments, one of the dose-stopping unit and counter elements, for example, the dose-stopping unit, and one of the zero-dose-stopping unit and further blocking unit, for example, the zero-dose-stopping unit, are fixed to the same member of the mechanism. This makes it possible to precisely define the relative positions of the components of the dose-defining mechanism with respect to the components of the zero-dose mechanism. The member of the mechanism may be, for example, a dose selector.

[0146] In some embodiments, a dose stop unit, such as a counter element, and the other of the counter elements, as well as a zero dose stop unit, such as a further block unit, and the other of the further block unit, are fixed to the same further member of the mechanism. This also allows for precise definition of the relative positions of the components of the dose-defining mechanism with respect to the components of the zero-dose mechanism. The further member may be, for example, a carrier that is rotationally movable with respect to the dose selector.

[0147] In some embodiments, one of the maximum dose stop and the maximum dose mechanism's blocking parts, such as the maximum dose stop and the zero dose stop, and one of the zero dose stop and the zero dose mechanism's further blocking parts, are fixed to the same member of the mechanism. Furthermore, the other of the maximum dose stop and the maximum dose mechanism's blocking parts, and the other of the zero dose stop and the zero dose mechanism's further blocking parts, such as the blocking part and the further blocking part, are fixed to the same further member of the mechanism. This provides precise alignment between the components of the maximum dose mechanism and the components of the zero dose mechanism.

[0148] Whether or not they are fixed to the same member of the mechanism, the maximum dose stop and / or minimum dose stop may be formed integrally with the member to which they are fixed. Similarly, the blocking and / or further blocking may be formed integrally with the member to which they are fixed.

[0149] In some embodiments, the blocking portion of the maximum dose mechanism forms a further blocking portion of the minimum dose mechanism. This makes it possible to precisely define the distance between the maximum dose position and the zero dose position.

[0150] In some embodiments, the mechanism includes a break to stop the movement of a nut when the button is released during dose administration. This provides the user with the possibility of interrupting dose administration by releasing the button. The break can be configured to disengage when the user activates the button again.

[0151] The rupture portion may include a first rupture portion and a second rupture portion that engages with the first rupture portion when the button is released during dose administration. The first rupture portion can engage with the second rupture portion axially by moving along the longitudinal axis of the mechanism relative to the second rupture portion.

[0152] The first fractured portion may be biased toward the second fractured portion, for example, by a spring.

[0153] In some embodiments, the first break portion rotates in a first direction relative to the second break portion during dose setting and rotates in a second direction opposite to the first direction during dose administration. This makes it possible to reset the brake portion during dose setting. Furthermore, the first break portion may be prevented from engaging with the second break portion at a predetermined rotational position, such as the end-of-dose position.

[0154] In some embodiments, the first fracture portion is configured as a circumferential rib extending longitudinally around the axis of the housing, and the second fracture portion is configured as a stop or counter element that moves along the circumferential rib during dose administration. This makes it possible to prevent the first and second fracture portions from engaging at specific locations along the circumferential rib with a simple configuration.

[0155] In some embodiments, the second break portion engages with the first break portion by friction when the button is released during dose administration. The first break portion can then move along the second break portion and be pushed against the second break portion when the button is released during dose administration. The mechanism can be configured so that the friction between the first and second break portions counteracts the force provided by the spring during dose administration.

[0156] In some embodiments, the first rupture portion includes a plurality of grooves, and the second rupture portion is configured to engage with at least one of the grooves when the button is released during dose dispensing. This provides a strong and reliable rupture mechanism.

[0157] In some embodiments, a first element of the blocking mechanism forms a first fracture portion of the fracture portion, and / or a second element of the blocking mechanism forms a second fracture portion of the fracture portion. This provides a compact configuration of the blocking mechanism and the fracture.

[0158] Generally, the mechanism may include a clutch having a first engaging portion and a second engaging portion, the clutch being closed during either dose setting or dose administration, and open during the other. The clutch is in an open state when the first and second engaging portions are not engaged, and is in a closed state when the first and second engaging portions are engaged.

[0159] In some embodiments, the mechanism includes a clutch that rotatably locks a nut onto the piston rod during dose dispensing and rotatably releases the nut from the piston rod during dose setting. By rotatably locking the nut onto the piston rod, the clutch allows the nut to move proximal to the piston rod simultaneously. For example, the clutch can rotatably lock the threads that connect the nut to the piston rod. The clutch can lock the nut onto the piston rod in a closed state and release the nut from the piston rod in a rotatably open state.

[0160] The clutch may include a first engaging portion and a second engaging portion, which may be configured to engage with each other to rotatably lock the nut to the piston rod. The first engaging portion and the second engaging portion may be configured to disengage from each other by relative axial movement.

[0161] The clutch can be configured to transition from an open state to a closed state when the button is moved and the mechanism transitions from a dose setting state to a dose administration state. One of the first and second engaging parts, for example the second engaging part, can be fixed axially to the button, and the other of the first and second engaging parts, for example the first engaging part, can be fixed axially to the housing. Additionally or alternatively, the first engaging part may be fixed axially to the drug dispensing member.

[0162] In some embodiments, the first engaging portion is fixed to the housing in the rotational direction, and the second engaging portion is fixed to the nut in the rotational direction.

[0163] The second engaging portion can be fixed in the rotational direction to the button and / or dose setting element.

[0164] In some embodiments, the clutch locks the nut to the piston rod in a rotational direction during dose administration, via a housing, for example, via a dose setting element and / or a button.

[0165] In some embodiments, the clutch operates between the button and the housing and / or between the dose setting element and the housing.

[0166] In some embodiments, the button is rotationally coupled to one of the first and second engaging portions, for example, permanently rotationally coupled. For example, the button may constitute one of the first and second engaging portions.

[0167] In some embodiments, the mechanism includes a further clutch which rotates the dose setting element to one end of the spring during dose setting and disengages the dose setting element from the other end of the spring during dose administration. Furthermore, the further clutch has a further first engaging portion and a further second engaging portion, the further first engaging portion being configured to move and engage with the further second engaging portion to rotate the dose setting element to one end of the spring. The further clutch allows tension to be applied to the spring during dose setting and, at the same time, prevents the dose setting element from rotating during dose administration when the spring is released again.

[0168] The further clutch may transition by the movement of a button from a closed state in which a further first engaging portion engages with a further second engaging portion to an open state in which the further first engaging portion is disengaged from the further second engaging portion. The movement of the button may also be a movement that transitions the mechanism from a dose setting state to a dose administration state.

[0169] In some embodiments, one of a further first engaging portion and a further second engaging portion is fixed to the dose setting element in the rotational and axial directions. This allows for the opening and closing of an additional clutch by the relative movement of the dose setting element with respect to the other of the further first engaging portion and the further second engaging portion.

[0170] In some embodiments, one of a further first engagement and a further second engagement is fixed to the button in both the rotational and axial directions. The dose setting element can then be fixed to the button at least in the rotational direction. For example, the dose setting element and the button may be fixed to each other in the rotational direction and movable in the axial direction. This makes it possible to fix the dose setting element axially to the other of the further first engagement and the further second engagement. For example, the dose setting element, as well as the other of the further first engagement and the further second engagement, can be fixed axially to the housing.

[0171] The dose setting element can be coupled to a further clutch via a button. The dose setting element and the button can be fixed to each other in a rotational direction. Furthermore, they may be fixed to one of the further first and second engaging parts, such as being fixed to a further second engaging part in a rotational direction.

[0172] In some embodiments, a further clutch acts between the dispensing member and the dose setting element. The dispensing member can then rotatably couple the dose setting element to one end of a spring.

[0173] In some embodiments, one of a further first engagement portion and a further second engagement portion is fixed to the drug dispensing member in the rotational direction. Additionally or alternatively, one of the further first engagement portion and a further second engagement portion can be fixed to the drug dispensing member in the axial direction.

[0174] In some embodiments, the additional clutch is located within the dispensing member. For example, the additional clutch may be located within the dosage sleeve or dispensing element of the dispensing member.

[0175] In some embodiments, the clutch includes a first engaging portion that engages with a second engaging portion to rotatably secure a nut to the piston rod during dose dispensing, and the second engaging portion of the clutch forms a further first engaging portion of a further clutch. This provides a compact structure for the clutch.

[0176] The nut can be fixed to the button and / or dose-setting element in a rotational direction. For example, the nut may be fixed to the button and / or dose-setting element in a rotational direction and movable in the axial direction. It may be coupled to the button and / or dose-setting element by a rotational lock. The rotational lock can be formed by the nut and one of the button and dose-setting element, for example, the button.

[0177] In some embodiments, the nut is screw-connected to the piston rod, such as by screw-engaging with the piston rod.

[0178] The nut may be rotatably movable relative to the piston rod when the mechanism is in the dose setting state, and may be fixed rotatably relative to the piston rod when the mechanism is in the dose dispensing state. Subsequently, rotation of the nut relative to the piston rod during dose setting can result in axial movement due to the screw connection between the nut and the piston rod. By locking the nut rotatably to the piston rod during dose dispensing, the screw connection between the nut and the piston rod is prevented, and the nut and piston rod can be fixed axially relative to each other.

[0179] The nut can be rotated by the dose setting element during dose setting, and axial movement can be performed by the screw connection to the piston rod. The rotation of the nut can cause it to axially translate distally along the threads located on the piston rod during dose setting, and proximally during dose cancellation. The axial movement of the nut relative to the piston rod can then define the axial movement of the piston rod during dose administration, and therefore the amount of pharmaceutical product discharged during dose administration.

[0180] In some embodiments, the spring is configured as a torsion spring.

[0181] This disclosure also relates to a drug delivery device having a mechanism according to this disclosure and a drug container attached to the mechanism. The drug container includes a plunger, and a bearing located on a piston rod is configured to engage with the plunger for dose delivery.

[0182] All embodiments and technical effects disclosed in connection with the mechanism according to the present invention also apply to drug delivery devices, and vice versa.

[0183] The drug delivery device can be configured as an injection device such as a pen injection device. The drug container may be configured to receive a cannula at its proximal end for administering the drug through the cannula.

[0184] Exemplary embodiments and functions of this disclosure are described herein in conjunction with the following schematic drawings. [Brief explanation of the drawing]

[0185] [Figure 1] This disclosure provides a perspective view of a pharmaceutical administration device. [Figure 2] This is a first side view of the drug delivery device. [Figure 3] This is a second side view of the drug delivery device. [Figure 4] This is an exploded view of a drug delivery device having the first mechanism according to this disclosure. [Figure 5] This is a cross-sectional view of a drug delivery device parallel to the longitudinal axis. [Figure 6] This is a first cross-sectional view of a drug delivery device in the dose setting state before setting the dose. [Figure 7] This is a second cross-sectional view of a drug delivery device in the dose setting state before setting the dose. [Figure 8] This is a first cross-sectional view of a drug delivery device in the dose setting state after the dose has been set. [Figure 9] This is a second cross-sectional view of a drug delivery device in the dose setting state after the dose has been set. [Figure 10] This is a first cross-sectional view through a drug delivery device in the dose-administering state before administering the set dose. [Figure 11] This is a second cross-sectional view of a drug delivery device in the dose-administering state before administering the set dose. [Figure 12] This is a first cross-sectional view of a drug delivery device in a dose-administered state after administering a set dose. [Figure 13]This is a second cross-sectional view of a drug delivery device in the dose-administering state after the set dose has been administered. [Figure 14] Objective view of the outer housing of the first mechanism from the distal end. [Figure 15] This is a perspective view of the outer housing from the proximal end. [Figure 16] This is a perspective view of the piston rod guide of the first mechanism from the distal end. [Figure 17] This is a perspective view of the piston rod guide from the proximal end. [Figure 18] This is a perspective view of the piston rod of the first mechanism. [Figure 19] This is a perspective view of the piston disc of the first mechanism. [Figure 20] This is a top view of the piston disc. [Figure 21] Figure 20 is a cross-sectional view of the piston disk along line AA. [Figure 22] This is a first perspective view of the nut of the first mechanism. [Figure 23] This is a second perspective view of the nut. [Figure 24] This is a side view of the nut. [Figure 25] Figure 24 shows a first cross-sectional view of the nut along line AA. [Figure 26] Figure 24 shows a second cross-sectional view of the nut along line BB. [Figure 27] This is a perspective view of the driver of the first mechanism. [Figure 28] A top view of the driver. [Figure 29] This is a perspective view of the drug delivery element of the drug delivery member of the first mechanism from the distal end. [Figure 30] This is a perspective view of the drug delivery elements from the proximal end. [Figure 31] This is a perspective view of the carrier for the drug delivery component of the first mechanism. [Figure 32] This is a side view of a career. [Figure 33] Figure 32 is a cross-sectional view of the carrier along line AA. [Figure 34] This is a perspective view of the connector of the first mechanism. [Figure 35] This is a bottom view of the connector. [Figure 36] This is a side view of the connector. [Figure 37] This is a top view of the connector. [Figure 38] This is a first perspective view of the dose-setting element of the first mechanism from the distal end. [Figure 39] This is a second perspective view of the dose-setting elements from the proximal end. [Figure 40] This is a side cross-sectional view of the dose setting element. [Figure 41] This is a perspective cross-sectional view of the dose setting element. [Figure 42] This is a perspective view of the intermediate member of the first mechanism. [Figure 43] This is a top view of the intermediate member. [Figure 44] This is a side view of the intermediate member. [Figure 45] This is a bottom view of the intermediate member. [Figure 46] This is a perspective view of the button of the first mechanism. [Figure 47] This is a side view of the button. [Figure 48] Figure 47 is a cross-sectional view of the button along line AA. [Figure 49] Figure 47 is a cross-sectional view of the button along line BB. [Figure 50] Figure 47 is a cross-sectional view of the button along line CC. [Figure 51] This is a subassembly of the first mechanism. [Figure 52] This is a perspective view of a first embodiment of the dose selector of the first mechanism, as seen from the distal end. [Figure 53] This is a perspective view of a first embodiment of a dose selector from the proximal end. [Figure 54] This is a longitudinal cross-sectional view of a first embodiment of a dose selector and a carrier for a drug dispensing member in a plane parallel to the longitudinal axis of the first mechanism in the dose setting state. [Figure 55] This is a first embodiment of the dose selector and a longitudinal cross-sectional view of the drug delivery member carrier in a plane parallel to the longitudinal axis of the first mechanism in a dose-administration state. [Figure 56] This is a radial section view of the first embodiment of the dose selector. [Figure 57] This is a bottom view of a second embodiment of a dose selector from the proximal end. [Figure 58] This is a bottom view of a third embodiment of a dose selector from the proximal end. [Figure 59] This is a top view of the first embodiment of a dose selector from the distal end. [Figure 60] This is a cross-sectional view of a second mechanism for an automated drug dispensing device according to this disclosure, in a dose-setting state before setting the dose. [Figure 61] This is a cross-sectional view of the second mechanism in the dose setting state after the dose has been set. [Figure 62] This is a cross-sectional view of the second mechanism in the dose-administered state before dose administration. [Figure 63] This is a cross-sectional view of the second mechanism in the dose-administered state after dose administration. [Figure 64] This is a cross-sectional view of a third mechanism for an automated drug dispensing device according to this disclosure, in a dose-setting state before setting the dose. [Figure 65] This is a cross-sectional view of the third mechanism in the dose-administered state after dose administration. [Figure 66] This is a cross-sectional view of the fourth mechanism for the automated drug dispensing device according to this disclosure, in the dose setting state before setting the dose. [Figure 67] This is a cross-sectional view of the fourth mechanism in the dose-administered state after dose administration. [Figure 68] This is a cross-sectional view of the fifth mechanism for the automated drug dispensing device according to this disclosure, in the dose setting state before setting the dose. [Figure 69] This is a cross-sectional view of the fifth mechanism in the dose-administered state after dose administration. [Figure 70]This is a detailed cross-sectional view of the sixth mechanism as disclosed herein. [Figure 71] This is a cross-sectional view of the seventh mechanism according to this disclosure, where no dosage has been set. [Figure 72] This is a cross-sectional view of the seventh mechanism according to this disclosure, where the maximum dose is set. [Figure 73] This is a side view of the drug delivery component of the seventh mechanism. [Figure 74] This is a perspective view of the drug delivery member of the seventh mechanism. [Figure 75] Figure 73 is a top cross-sectional view of the drug delivery member of the seventh mechanism along line AA. [Figure 76] This is a perspective view of the driver of the seventh mechanism. [Figure 77] This is a cross-sectional perspective view of the outer housing of the seventh mechanism. [Figure 78] This is a side view of the eighth mechanism according to this disclosure in the dose setting state. [Figure 79] This is a side view of the eighth mechanism in a dose-administered state. [Figure 80] This is a cross-sectional view of the eighth mechanism according to this disclosure, in a dose setting state where no dose has been set. [Figure 81] This is a cross-sectional view of the eighth mechanism in a dose setting state where the maximum dose has been set. [Figure 82] This is a cross-sectional view of the eighth mechanism in the dose-administered state before administering the maximum dose. [Figure 83] This is a perspective view of the operating unit of the eighth mechanism. [Figure 84] This is a side view of the operating unit of the eighth mechanism. [Figure 85] This is a cross-sectional view of the operating unit of the eighth mechanism along line AA in Figure 84. [Figure 86] This is a perspective view of the outer housing of the eighth mechanism. [Figure 87] This is a side view of the outer housing of the eighth mechanism. [Figure 88] Figure 87 is a cross-sectional view of the outer housing of the eighth mechanism along line AA. [Figure 89]This is a side view of the driver and drug delivery elements of the eighth mechanism. [Figure 90] Figure 89 is a cross-sectional view of the driver and drug delivery elements of the eighth mechanism along line AA. [Figure 91] Figure 89 is a cross-sectional view of the driver of the eighth mechanism along line BB. [Figure 92] This is a perspective view of the drug delivery component of the eighth mechanism. [Figure 93] This is a side view of the drug delivery component of the eighth mechanism. [Figure 94] Figure 93 is a cross-sectional view of the drug delivery member of the eighth mechanism along line AA. [Figure 95] This is a cross-sectional view of the ninth mechanism according to this disclosure, in a dose-setting state where no dose has been set. [Figure 96] This is a perspective view of the driver of the ninth mechanism as disclosed in this disclosure. [Figure 97] This is a side view of the driver of the ninth mechanism according to this disclosure. [Figure 98] This is a top view of the driver of the ninth mechanism on the distal end of the driver. [Figure 99] This is a side view of the drug delivery element of the ninth mechanism. [Figure 100] This is a top view of the drug delivery element of the ninth mechanism. [Modes for carrying out the invention]

[0186] Figures 1 to 3 show the drug delivery device 300 according to this disclosure. The drug delivery device 300 is configured as a pen-type injection device suitable for administering a dose of medicine by injection through the patient's skin. The drug delivery device 300 has a substantially cylindrical shape, extending from a distal end 12 facing away from the injection site to a proximal end 14 located at the injection site. The proximal direction 1 points towards the injection site, i.e., from the distal end 12 to the proximal end 14. The distal direction is oriented in the opposite direction to the proximal direction 1, and points from the proximal end 14 to the distal end 12.

[0187] The drug administration device 300 includes a first mechanism 354 for setting the dose of the drug to be administered to the injection site and for administering the set dose. A container holder 305, configured to receive a drug container containing the drug to be administered, is connected to the proximal end of the first mechanism 354. A needle connector 306 for connecting a cannula to the drug administration device 300 is located at the proximal end of the container holder 305. The needle connector 306 is configured as a shape-matching connector. It may be configured, exemplary, as a threaded connector, or as a bayonet lock, Luer lock, etc.

[0188] The first mechanism 354 is configured as an automated mechanism that automatically administers a set dose after the user triggers a dose administration. Thus, sufficient force to administer the set dose is provided by the mechanism's spring, and as a result, the user of the device does not need to provide force to drive the injection.

[0189] At the distal end 12, the first mechanism 354 includes an actuation unit 316 for setting a dose and triggering an injection of the set dose. The actuation unit 316 includes a dose setting element 22 and a button 318.

[0190] The dose setting element 22 has a cylindrical outer surface configured to be grasped by a user of the drug delivery device 300 in order to set the dose to be administered by rotating the dose setting element 22 around the longitudinal axis of the first mechanism 354. Thereafter, rotation in one circumferential direction increases the set dose, and rotation in the opposite circumferential direction decreases the set dose. The set dose is indicated in a window 166 formed within the housing 332 of the first mechanism 354.

[0191] Button 318 is configured as a push button. It is oriented approximately perpendicular to the longitudinal axis and has an end face 80 located at the distal end 12 of the first mechanism 354. Button 318 is configured to be pressed proximal 1 by the user of the device to transition the first mechanism 354 from the dose setting state to the dose administration state. This is done by the user pressing the end face 80 of button 318. Proximal movement of button 318 initiates automatic dose administration.

[0192] In the embodiments shown in Figures 1 to 3, the dose setting element 22 and the button 318 of the actuation unit 316 are firmly connected to each other so as to be fixed to each other in the axial and rotational directions. Therefore, proximal movement of the button 318 also results in proximal movement of the dose setting element 22, and rotation of the dose setting element 22 also results in rotation of the button 318.

[0193] The dose setting element 22 and the button 318 of the actuation unit 316 are configured as two separate parts having a first mechanism 354. In other embodiments, the dose setting element 22 and the button 318 can also be formed integrally as a single part.

[0194] The first mechanism 354 is located between the actuation unit 316 and the housing 332 and includes a housing connector that forms an outer housing component. The housing connector is exemplary configured as a dose selector 360.

[0195] Figure 4 shows an exploded view of the drug delivery device 300, and Figure 5 shows a cross-sectional view of the drug delivery device 300 parallel to the longitudinal axis, with the first mechanism 354 in the dose setting state.

[0196] The housing 332 includes an outer housing 333 that is firmly connected to the piston rod guide 342 of the housing 332. The outer housing 333 is configured as a hollow, substantially cylindrical member, thereby having a sleeve shape. The outer housing 333 is fixed to the piston rod guide 342 in the axial and rotational directions by a connector 375. Thus, the outer housing 333 and the piston rod guide 342 form a single functional component of the drug delivery device 300.

[0197] Connector 375 is located at the proximal end of the outer housing 333. It is exemplary configured as a snap-mating connector that irreversibly snaps the outer housing 333 into the piston rod guide 342. In other embodiments, the connector may be configured as another shape-mating connector, such as a screw connection. It may also be configured as an adhesive bond, such as an adhesive connection. Connector 375 engages with the outer body 387 of the piston rod guide 342. The outer body 387 is configured as a ring-shaped portion of the piston rod guide 342 and is located at the proximal end of the piston rod guide 342. Connector 375 engages with the distal side of the outer body 387.

[0198] The container holder 305 has a substantially cylindrical hollow shape and receives a pharmaceutical container 348 inside. It is coupled to the housing 332 by a connector 307 located at the distal end of the container holder 305. The connector 307 engages with the piston rod guide 342 on the proximal side of the outer body 387 of the piston rod guide 342. The connector 307 is configured as a shape-mating connector, i.e., a snap-mating connector. In other embodiments, the connector 307 may also be configured as another shape-mating connector, such as a screw connection, or as an adhesive bond.

[0199] At the needle end 349 of the pharmaceutical container 348, where the needle end 349 is located at the proximal end of the pharmaceutical container 348, the pharmaceutical container 348 is provided with a partition wall that seals the inside of the pharmaceutical container 348. The partition wall is configured to be punctured by a double-ended cannula when the cannula is mounted on the needle connector 306 of the container holder 305.

[0200] In the embodiments shown in Figures 1 to 5, the drug administration device 300 is configured as a disposable device to be discarded after the last dose from the drug container 348 has been administered. The container holder 305 is irremovably connected to the housing 332 by a connector 307. The container holder 305 can then not be removed from the housing 332 without breaking the first mechanism 354 and / or the container holder 305. In other embodiments, the drug administration device 300 may also be configured as a reusable device that allows a new drug container 348 to be attached after the last dose from the drug container 348 attached to the first mechanism 354 has been administered. In such embodiments, the connector 307 may be configured as a removable connector such as a screw connection or a bayonet lock.

[0201] The drug delivery device 300 includes a cap 301 configured to be releasably attached to the proximal end 14 of the drug delivery device 300 to cover the container holder 305 and the needle connector 306.

[0202] To dispense the medicine from the medicine container 348, the first mechanism 354 includes a piston rod 44. The piston rod 44 protrudes from the first mechanism 354 at its proximal end, thereby protruding through the piston rod guide 342. At the proximal end of the piston rod 44 is a bearing 46 that pushes a movable plunger 350 (see Figure 5) which seals the medicine container 348 toward its distal end.

[0203] The piston rod 44 is fixed in the rotational direction to the piston rod guide 342 and the outer housing 333. The piston rod 44 has male threads that engage with the female threads of the nut 38. The nut 38 is configured as a hollow, substantially cylindrical member disposed around the piston rod 44.

[0204] The nut 38 is connected to the button 316 of the actuation unit 318, thereby fixing the nut 38 to the button 316 in the rotational direction and making it movable in the axial direction. Thus, the nut 38 is connected to the button 316 by rotational locking. In the embodiment shown in Figure 4, the first mechanism 354 exemplary includes a spline connection between the nut 38 and the cylindrical proximal portion of the button 316 as rotational locking. The distal portion of the nut 38 is received within the button 316. The spline connection includes a longitudinal groove 106 on one of the nut 38 and the button 316, and a corresponding longitudinal ridge provided on the other of the nut 38 and the body 316 that engages with the groove 106. Exemplarily, the longitudinal groove 106 is provided on the outer surface of the nut 38, and the longitudinal ridge is provided on the inner surface of the button 316.

[0205] The button 316 is firmly connected to the dose setting element 22 by the intermediate member 20. The intermediate member 20 is located within the cylindrical portion of the dose setting element 22 and is fixed to both the dose setting element 22 and the button 316 in the rotational and axial directions.

[0206] The first mechanism 354 further comprises a driver 336 having a substantially cylindrical hollow body and disposed around the nut 38. The driver 336 is screwed to the housing 323, i.e., the piston rod guide 342, via a drive thread 337. It engages with the piston rod guide 342 via the drive thread 337. The drive thread 337 is formed between the distal inner body 388 of the housing 332 and the driver 336. The inner body 388 forms the distal portion of the piston rod guide 342, which is located distal to the outer body 387.

[0207] The female threads of the drive screw thread 337 are formed on the inner surface of the inner body 388, and the male threads of the drive screw thread 337 are formed on the outer surface of the body of the driver 336.

[0208] The first mechanism 354 further comprises a drug dispensing member 323 having a carrier 24 that forms a first part of the drug dispensing member 323 and a drug dispensing element 334 that forms a second part of the drug dispensing member 323. The carrier 24 forms a coupling member that rotates the drug dispensing member 323 to the dose setting element 22 during dose setting.

[0209] In the embodiments shown in Figures 1 to 5, the drug delivery element 334 and the carrier 24 are firmly connected to each other so as to be fixed axially and rotationally relative to each other. In the illustrated embodiments, the drug delivery element 334 and the carrier 24 are configured as two separate parts joined together. In other embodiments, the drug delivery element 334 and the carrier 24 may also be configured as a single, materially homogeneous element.

[0210] The drug delivery member 323 is fixed axially within the housing 332 and held movably in the rotational direction. Both the drug delivery element 334 and the carrier 24 are configured as substantially cylindrical hollow members. The drug delivery element 334 is positioned proximal 1 relative to the carrier 24.

[0211] The dispensing element 334 forms a dosage sleeve. The dispensing element 334 surrounds the piston rod 44 and the nut 38. Furthermore, it surrounds the inner body 388 and the driver 336 of the housing 332. In other embodiments, it may surround only the driver 336 and not the inner body 388.

[0212] The driver 336 is rotationally movable relative to the dispensing member 323, fixed axially, and connected to the dispensing member 323 by a connector 339. Thereafter, it directly engages with the dispensing member 323, i.e., with the dispensing element 334 of the dispensing member 323. The connector 339 is configured as a rotational lock. It is exemplary a spline connection and includes a longitudinal ridge that engages with a corresponding longitudinal groove. In this embodiment, the longitudinal ridge is exemplary formed on the outer surface of the driver 336, and the dispensing member 323 includes a longitudinal groove corresponding to its inner surface, i.e., the inner surface of the dispensing element 334. In other embodiments, the connector 339 can also otherwise rotately fix the driver 336 to the dispensing member 323.

[0213] The spring 40 is coupled between the driver 336 and the housing 332. Thus, the spring 40 is directly coupled between the driver 336 and the housing 332. The first end 461 of the spring 40 is attached to the driver 336, and the second end 462 of the spring 40 is attached to the housing 332, exemplary to the piston rod guide 342 of the housing 332. The spring 40 surrounds the inner body 388 of the housing 332.

[0214] The dose selector 360 is configured as a hollow, substantially cylindrical member. It surrounds the drug delivery member 323, i.e., the carrier 24 of the drug delivery member 323. Furthermore, the dose selector 360 is located inside the housing 332 and protrudes from the distal end of the housing 332.

[0215] The dose selector 360 is axially fixed to the actuation unit 318 and rotatably connected. Thus, the distal end of the dose selector 360 engages with the proximal end of the dose setting element 22, exemplary, with the proximal end of the cylindrical body of the dose setting element 22. The dose selector 360 is further rotatably fixed to the housing 332 and axially movable. The rotational lock 152 between the dose selector 360 and the housing 332 is configured as a spline connection. The spline connection includes a longitudinal ridge that engages with a corresponding longitudinal groove. Exemplarily, the spline connection includes a longitudinal groove formed on the inner surface of the housing 332 and a corresponding longitudinal ridge formed on the outer surface of the dose selector 360. In other embodiments, the rotational lock 152 may also be configured in other ways. For example, the ridge may be provided on the housing 332, and the groove may be provided on the dose selector 360.

[0216] The connector 26 is positioned around the medication dispenser 323, i.e., around the carrier 24. The connector 26 is fixed axially to the medication dispenser 323 and movable in the rotational direction. It is positioned around the coupling section 112 of the carrier 24. The coupling section 112 is located on the outer surface of the medication dispenser 323 and is recessed relative to the outer surface. The connector 26 is fixed axially to the medication dispenser 323 by abutting both longitudinal ends of the recessed section 112.

[0217] The connector 26 is rotatably fixed to the housing 332, thereby rotatably fixed to the housing 332 via the dose selector 360. The rotation lock 150 between the connector 26 and the dose selector 360 rotatably fixes the connector 26 to the dose selector 360 while allowing axial movement. The rotation lock 150 is exemplary configured as a spline connection having longitudinal ribs provided on the outer surface of the connector 26 and corresponding longitudinal grooves provided on the inner surface of the dose selector 360. In other embodiments, the rotation lock 150 can be configured in a different way, for example, the grooves may be provided on the connector 26 and the ribs on the dose selector 360.

[0218] As can be seen in Figure 5, the proximal portion of the button 318 protrudes into the distal portion of the medication dispensing member 323. As a result, the button 318 protrudes into the carrier 24 of the medication dispensing member 323.

[0219] Button 318 is biased against the housing 332 and the medication dispenser 323 by a biasing member 250, which is exemplary configured as a compression spring. The biasing member 250 is located between the medication dispenser 323 and button 318. In this embodiment, since button 318 is fixed axially against the dose setting element 22 and the dose selector 360, the biasing member 250 also biases the dose setting element 22 and the dose selector 360 distally.

[0220] The retainer 97 prevents the button 318 and the dose setting element 22 from moving distally away from the housing. The retainer 97 acts between the button 318 and the medication dispenser 323. It restricts distal movement of the button 318 and the dose setting element 22 relative to the housing 332, but allows proximal movement.

[0221] The retainer 97 has a first retainer element 98a that engages with a second retainer element 102 to prevent distal movement of the button 318 and the dose setting element 22. The first retainer element 98a is exemplary provided on the button 318, i.e., on the outer surface of the proximal portion of the button 318. The second retainer element 102 is exemplary provided on the medication dispensing member 323. The first retainer element 98a is configured as a projection located on the outer surface of the button 318, and the second retainer element 102 is configured as a ledge extending radially inward.

[0222] The biasing member 250 biases the button 318 distally toward the second retainer element 102. Movement of the button 318 proximal 1 is possible against the force provided by the biasing member 250, disengaging the first retainer element 98a from the second retainer element 102.

[0223] The first mechanism 354 acts between the nut 38 and the piston rod 44 and includes a clutch 113 formed exemplary between the dose setting element 22 and the connector 26. The first mechanism 354 further includes a further clutch 107 that acts on the one hand between the dose setting element 22 and on the other hand between the drug dispensing member 323 and the driver 336. The further clutch 107 is exemplary formed between the dose setting element 22 and the drug dispensing member 323.

[0224] Figure 6 shows a first cross-sectional view through the drug delivery device 300 in the first cross-section, and Figure 7 shows a corresponding second cross-sectional view through the drug delivery device 300 in a second cross-section perpendicular to the first cross-section, thereby showing the drug delivery device 300 in a dose-setting state before dose setting.

[0225] In the dose setting state, the button 318 and dose setting element 22 are distal to the dispensing member 323. In this position, the dose setting element 22 is rotatably fixed to the dispensing member 323 via an additional clutch 107 which is in the closed state. Furthermore, the clutch 113 is in the open state such that the nut 38 and dose setting element 22 are rotatably movable relative to the piston rod 44 and housing 332.

[0226] When the dose setting element 22 is rotated during dose setting, the dispensing member 323 rotates because a further clutch 107 between the dose setting element 22 and the dispensing member 323 is closed. The rotation of the dispensing member 323 also forces a corresponding rotation of the driver 336, and therefore the driver moves axially relative to the piston rod guide 342 by its screw connection to the piston rod guide 342 via the drive thread 337. When increasing the set dose, the driver 336 moves distally away from the piston rod guide 342, and when decreasing the set dose, the driver 336 moves proximal 1 toward the piston rod guide 342.

[0227] The rotation of the driver 336 during dose setting stores energy in the spring 40. This causes the spring 40 to deform, and increasing the set dose increases the energy stored in the spring 40. Decreasing the set dose relaxes the spring 40, and the energy stored in the spring 40 decreases. When no dose is set, the spring 40 may be pre-tensioned to bias the driver 336 in the proximal direction 1.

[0228] Since the nut 38 is fixed to the button 318 in the rotational direction, the rotation of the dose setting element 22 also causes the nut 38 to rotate during dose setting. This causes the nut 38 to screw in along the piston rod 44 and also move distally. The pitch of the threaded connection 189 of the piston rod 44 and the pitch of the drive thread 337 are adapted so that the nut 38 and the driver 337 move essentially the same axial distance when rotated. Thus, the nominal pitch of the drive thread 337 is slightly higher than the nominal pitch of the threaded connection 189 between the piston rod 44 and the nut 38, preventing mutual obstruction of the nut 38 and the driver 336 regardless of manufacturing tolerances. In detail, the minimum allowable pitch of the drive thread 337 is greater than the maximum allowable pitch of the threaded connection 189 between the nut 38 and the piston rod 44.

[0229] During dose setting, the dosing member 323 rotates relative to the dose selector 360 and the housing 332. As will be described in detail below, the first mechanism 354 has a dose definition mechanism 115 that acts between the dosing member 323 and the housing 332. The dose definition mechanism 115 defines discrete relative rotational positions of the dosing member 323 relative to the housing 332 corresponding to doses that can be set by the first mechanism 354. At each rotational position of the dosing member 323 corresponding to a settable dose, the dose definition mechanism 115 locks the dosing member 323 against the force provided by the spring 40 in the rotational direction relative to the housing 332. Thereby, the user of the first mechanism 354 can release the dose setting element 22 without decreasing the set dose. Between rotational positions corresponding to settable doses, the dose definition mechanism 115 allows the dosing member 323 to rotate freely so that it returns to the next lower settable dose. Thereby, inadvertent setting of intermediate doses is prevented.

[0230] The dosing member 323 includes a label 168 provided on the outer surface of the dosing member 323 and visible through the window of the housing 332 when the dose is set. Thereby, the label 168 indicates that the dose has been set and can indicate, for example, the amount of the set dose.

[0231] In some embodiments of the first mechanism 354, only a single dose can be set by the user. In other embodiments, two or more doses, such as two or more doses, can be set by the user. For each settable dose, the dosing member 323 includes a label 168 corresponding to its outer surface.

[0232] FIG. 8 shows a first cross-sectional cut through the pharmaceutical administration device 300 in the first cut plane, and FIG. 9 shows a corresponding second cross-sectional cut through the pharmaceutical administration device 300 in the second cut plane, whereby the first mechanism 354 is in the dose setting state after setting the dose.

[0233] The nut 38 has been moved distally by a dose distance 3 from the proximal end 14 of the first mechanism 354. The driver 336 has similarly moved a corresponding distance distally.

[0234] To inject the set dose, the user moves button 318 proximally 1. This also moves the dose setting element 22 and dose selector 360 proximally 1 relative to the housing 332 and the drug delivery member 323. This opens an additional clutch 107 between the drug delivery member 323 and the dose setting element 22, and closes a clutch 113 between the dose setting element 22 and the connector 26 surrounding the drug delivery member 323.

[0235] By moving the button 318 to a proximal position, the first mechanism 354 transitions from its dose setting state to its dose administration state.

[0236] Figure 10 shows a first cross-sectional view through the drug delivery device 300 in the first cross-section, and Figure 11 shows a corresponding second cross-sectional view through the drug delivery device 300 in the second cross-section, thereby the first mechanism 354 is in a dose-administering state before administering the set dose.

[0237] Closing the clutch 113 between the dose setting element 22 and the connector 26 rotatably secures the nut 38 to the housing 332 via the button 318, dose setting element 22, connector 26, and dose selector 360. Since the piston rod 44 is rotatably fixed to the housing 332, closing the clutch 113 also rotatably secures the nut 38 to the piston rod 44. Closing the clutch 113 also prevents the dose setting element 22 and the button 318 from rotating relative to the housing 332. Further release of the clutch 107 rotatably disengages the dose setting element 22 from the dispensing member 323 and the driver 336.

[0238] The transition of the first mechanism 354 from the dose setting state to the dose administration state by moving the button 318 in the proximal direction 1 also disengages the dose definition mechanism 115, and as a result, the dispensing member 323 is no longer prevented from rotating relative to the housing 332 in a rotational position corresponding to the settable dose. Generally speaking, the disengagement of the dose definition mechanism 115 thus allows the driver 336 to rotate freely relative to the housing 332, thereby enabling the driver 337 to be driven by the spring 40.

[0239] This rotation screws the driver 336 into the piston rod guide 342 in the proximal direction 1, and therefore moves the driver 336 axially in the proximal direction 1 as well. When it moves proximal, the driver 336 comes into contact with the nut 38 via the axial stop 194. This axially locks the driver 336 to the nut 38 so that the driver 336 and the nut 38 move together in the proximal direction 1.

[0240] In this embodiment, the axial stop portion 194 is provided at the proximal end of the nut 38. It is exemplary configured as an annular ring projecting radially from the nut 38. When moving proximal to the nut 38, the driver 336 engages with the axial stop portion 194 at its proximal end.

[0241] The closing of the clutch 113 locks the nut 38 rotatably to the piston rod 44 and housing 332 via the button 318, dose setting element 22, connector 24, and dose selector 360. This engages the drive thread 337 so that the nut 38 and piston rod 44 are axially fixed to each other. The axial advance of the nut 38 causes the piston rod 44 to advance in the corresponding axial direction. As a result, the spring 40 automatically drives the driver 336, nut 38, and piston rod 44 in the proximal direction 1 to administer the set dose.

[0242] Figure 12 shows a first cross-sectional view through the drug delivery device 300 in the first cross-section, and Figure 13 shows a corresponding second cross-sectional view through the drug delivery device 300 in the second cross-section, thereby indicating that the first mechanism 354 is in a dose-delivering state after delivering a set dose. The piston 44 and the bearing 46 located at the proximal end of the piston rod 44 are moved 1 proximal by a dose distance 3. This also pushes the plunger 350 1 proximal by a dose distance 3, thereby discharging an amount of drug corresponding to the volume covered by the dose distance 3.

[0243] As can be seen in Figure 5, the button 318, and exemplary the medication dispenser 323, are also held axially within the housing 332 by a blocker 430 that acts between the button 318 and the housing 332, preventing the button 318 from moving axially in the distal direction 1 relative to the housing 332. In this embodiment, the blocker 430 acts between the housing 332 and the medication dispenser 323. The blocker 430 prevents distal movement of the medication dispenser 323 relative to the housing 332. It is fixed axially and rotationally relative to the housing 332 and rotatably engages with the medication dispenser 323, i.e., the medication dispenser element 334. In this embodiment, the blocker 430 engages with the distal opposing surface of the medication dispenser 323, exemplary the distal end surface of the medication dispenser 323. In other embodiments, the blocker 430 may also engage with other parts of the medication dispenser 323. The drug dispensing member 323, or drug dispensing element 334, forms the counter member of the blocker 430.

[0244] The blocker 430 is located directly on the outer housing 333 of the housing 332 and protrudes from the inner surface of the outer housing 333. In other embodiments, the blocker 430 may also be located on an additional housing component fixed to the outer housing 333 at least axially. For example, the additional housing component may be fixed to the outer housing 333 in both axial and rotational directions.

[0245] The connection between the additional housing component and the outer housing 333 may be configured as a shape-fit connection, such as a snap-fit ​​connection or a screw-fit connection. The connection may be configured to assemble the additional housing component to the outer housing 333 after the dispensing member 323 has been placed inside the outer housing 333. For example, the connection may be configured to allow the assembly of the additional housing component to the outer housing 333 from the distal end of the outer housing 333.

[0246] The blocker 430 is configured as a unidirectional blocker that allows the drug delivery member 323 to pass in the proximal direction 1 but prevents it from passing in the distal direction. The blocker 430 bends away from the drug delivery member 323 when it passes in the proximal direction 1 and forms a flexible element that interferes with the drug delivery member 323 when it passes in the distal direction. After the drug delivery member 323 has passed, the blocker 430 snaps into a blocking position that prevents distal movement of the drug delivery member 323. As shown in Figure 5, the first mechanism 354 may include additional blockers 430. The additional blockers 430 may be distributed around the housing 332.

[0247] In other embodiments, the blocker 430 may also be configured as a rigid element. The blocker 430 can then be fixed to the housing 333 after at least a portion of the drug delivery member 323, such as the drug delivery element 334, has been placed inside the housing 332.

[0248] In an alternative embodiment, the blocker 430 may also be fixed to the drug delivery member 323. The blocker 430 can then interfere with features such as projections or grooves provided on the inner surface of the housing 332.

[0249] Movement of the dosing member 323 in the proximal direction 1 is inhibited by the housing 332, i.e., by the piston rod guide 342. The dosing member 323 thereby abuts against the distal facing surface of the proximal outer body 387 of the piston rod guide 342. Generally speaking, the dosing member 323 abuts against the distal facing surface of the housing 332. In other embodiments, the distal facing surface may also be provided, for example, on the outer housing 333.

[0250] In other embodiments of the first mechanism 354, the blocker 430 may be configured to inhibit or prevent movement of the dosing member 323 only in the distal direction. Then, movement of the button 318 and / or the dose setting element 22 can be inhibited or prevented by other mechanisms.

[0251] As can also be seen from FIG. 5, the first mechanism 354 includes a stop 373 that restricts proximal movement of the button 318 during dose administration. The stop 373 is axially fixed to the housing 332. This interferes with a component that is axially fixed relative to the button 318. In this embodiment, the stop 373 interferes with a housing connector formed by the dose selector 360. When the dose administration state is reached, the axially fixed component formed by the dose selector 360 abuts against the stop 373, thus preventing further proximal movement of the button 318. The housing 332 forms a first stop portion of the stop 373, and the dose selector 360 forms a second stop portion of the stop 373.

[0252] In this embodiment, the stop 373 is located at the proximal end of one of the grooves of the rotational locking 152 formed on the inner surface of the dose selector 360. For example, the stop 373 may be formed by the proximal end of one of the grooves.

[0253] The stopper 373 is located directly on the outer housing 333 and, exemplary, is formed integrally with the outer housing 333. In other embodiments, the stopper 373 may also be located on a separate component that is fixed at least axially, such as being fixed axially and rotationally to the outer housing 333. In some embodiments, the separate component may also include a blocker 430.

[0254] As can be seen in Figure 5, the first mechanism 354 may be equipped with an additional stopper 373. The stopper 373 may be distributed circumferentially around the longitudinal axis of the first mechanism 354.

[0255] In an alternative embodiment, a stopper that restricts the proximal movement of the button 318 during dose administration may also act between the button 318 and the drug delivery member 323. Such a stopper 374 is also shown in Figure 5. It is configured as a radial projection located on the outer surface of the proximal portion of the button 318. The projection thus surrounds the proximal portion of the button 318 in a circumferential direction. As the button 318 moves proximal to the drug delivery member 323, the stopper 374 abuts against a ring that protrudes radially inward at the distal end of the drug delivery member 323, which also forms a second retainer element 102. This can also be seen in Figures 10 to 13. In other embodiments, the counter elements of the second retainer element 102 and the stopper 374 may be formed as separate features.

[0256] Although both the stopping section 373 and the stopping section 374 are shown in Figures 5 to 13, the first mechanism 354 may feature only the stopping section 373 or the stopping section 374.

[0257] In the first mechanism 354, the button 318 is the last component to be added to the first mechanism 354 during assembly. The first mechanism 354 includes a priming mechanism that allows adjustment of the axial position of the piston rod 44 and bearing 46 relative to the housing 332 in the pre-assembled state of the first mechanism 354. In this pre-assembled state, the button 318 is inserted into the dispensing member 323 but not fully pushed in the proximal direction 1, and is engaged with the intermediate member 20 to be fixed axially and rotationally to the dose setting element 22. In this position, a further first retainer element 98b located proximal to the first retainer element 98a engages with the second retainer element 102. The button 318 is then axially constrained distally to the housing 332 and can be moved rotationally relative to the dose setting element 22. This allows the nut 38 to be rotated by rotating the button 318, thereby enabling the piston rod 44 to move axially via the screw connection between the nut 38 and the piston rod 44. Details of this priming mechanism are described in U.S. Patent Application Publication No. 17 / 981231, which is incorporated in its entirety by reference. In particular, the disclosure of the priming mechanism described in U.S. Patent Application No. 17 / 981231 is incorporated in this disclosure by reference.

[0258] Figure 14 shows a perspective view of the outer housing 333 of the first mechanism 354 from the distal end, and Figure 15 shows a perspective view of the outer housing 333 from the proximal end. A groove for the rotation lock 154 is formed on the inner surface 371 of the outer housing 333. Furthermore, three of the connectors 375 protrude from the proximal end of the outer housing 333.

[0259] Figure 16 shows a perspective view of the piston rod guide 342 of the first mechanism 354 as seen from the distal end, and Figure 17 shows a perspective view of the piston rod guide 342 as seen from the proximal end. Female threads 172 of the drive thread 337 are formed on the inner surface of the inner body 388. A spring connector 386 is formed on the proximal end and the outer surface of the inner body 388 for securing the second end 462 of the spring 40 to the piston rod guide 342. The spring connector 386 is exemplary formed as an opening in the outer surface of the inner body 388, and the second end 462 of the spring 40 is bent to engage with this opening.

[0260] As can be seen in Figure 16, the housing connector 382 is formed on the distal side of the outer body 387 of the piston rod guide 342. The housing connector 382 is configured as a plurality of recessed sections in which the corresponding snap hook of the connector 375 formed at the proximal end of the outer housing 333 engages when the outer housing 333 is assembled to the piston rod guide 342.

[0261] The piston rod 44 is guided within an opening 186 of the piston rod guide 342, which can be seen in Figure 17. The opening 186 is formed as a non-circular axial opening corresponding to the non-circular cross-section of the piston rod 44. Thus, the piston rod 44 is axially movable relative to the piston rod guide 342 but cannot rotate relative to the piston rod guide 342.

[0262] The container connector 384 is located adjacent to the opening 186. The container connector 384 is formed by an opening that receives the corresponding snap-fitting hook of the connector 307 formed at the distal end of the container holder 305.

[0263] Figure 18 shows a perspective view of the piston rod 44 of the first mechanism 354. The piston rod 44 has male threads 190 on its outer surface that form part of a threaded connection 189 between the piston rod 44 and the nut 38. In addition, the piston rod includes two opposing flattened sections 191 that provide a non-circular cross-section of the piston rod 44 corresponding to the non-circular cross-section of the opening 186 of the piston rod guide 342. These non-circular cross-sections lock the piston 44 to the piston rod guide 342 in the rotational direction while allowing relative axial movement.

[0264] The piston rod 44 includes a proximal connector 198 at its proximal end that engages with a bearing 46 and holds the bearing 46 to the piston rod 44. The piston rod 44 includes a stopper 199 at its distal end, which is configured as a thickened, threadless section of the piston rod 44.

[0265] Figure 19 shows a perspective view of the bearing 46 of the first mechanism 354, Figure 20 shows a top view of the bearing 46, and Figure 21 shows a cross-sectional view of the bearing 46 along line AA shown in Figure 20. The bearing 46 includes a bearing connector 200 configured as a central opening. The bearing connector 200 features an inclined side surface that snaps onto the proximal connector 198 of the piston rod 44 when the proximal connector 198 is inserted into the central opening 200.

[0266] Figures 22 to 26 show the nut 38 of the first mechanism 354. On the inner surface of the central opening 39, the nut 38 includes the female threads 192 of the threaded connection 189 between the piston rod 44 and the nut 38. Thus, the female threads 192 are located at the proximal end of the nut 38. The piston rod 44 and the nut 38 can move relative to each other in a combination of forced-guided axial and rotational movements.

[0267] The nut 38 features an axial stop portion 194 formed as an annular projection on its outer surface. The axial stop portion 194 is located within the proximal end section of the nut 38. The axial stop portion 194 contacts the front surface 196 of the driver 336 during dose dispensing. To reduce friction during dose dispensing, the axial stop portion 194 is formed as a projection extending distally from the annular projection. This reduces the contact area between the driver 376 and the nut 38. In an alternative embodiment, a bearing element such as a ball bearing and / or glide disc made of a low-friction material may be positioned between the axial stop portion 194 and the front surface 196 of the driver 336.

[0268] The first mechanism 354 includes a final dose mechanism that prevents the dial from setting a dose greater than the remaining amount of medicine in the medicine container 348. The final dose mechanism is formed by a stop portion 199 at the distal end of the piston rod 44 and an axial stop portion 193 provided on the inner surface of the opening 39 of the nut 38.

[0269] As the dose is set and administered repeatedly, the piston rod 44 moves continuously in the proximal direction 1 relative to the nut 38. This continuously decreases the distance between the stop portion 199 on the piston rod 44 and the axial stop portion 198 on the inner surface of the nut 38 after each dose administration. Before administering the first dose from the medicine container, the distance between the stop portion 199 and the axial stop portion 198 has an initial value. The initial value is adapted to decrease with repeated administration of the set dose by an amount that prevents further distal movement of the nut relative to the piston rod 44 if the user sets a dose greater than the remaining amount of medicine in the medicine container 348.

[0270] Figure 27 shows a perspective view of the driver 336 of the first mechanism 354, and Figure 28 shows a top view of the driver 336. The driver 336 has an opening 338 for receiving a nut 38. The opening 338 is configured as a central axial opening. In its distal end section, the driver 336 includes a spring connector 340 configured to connect to the first end 461 of the spring 40. Furthermore, the driver 336 includes a connector 339 in its distal end section. The connector 339 includes two radially outward ribs that engage with the dispensing element 334 of the dispensing member 323.

[0271] Figure 29 shows a perspective view of the drug delivery element 334 of the drug delivery member 332 of the first mechanism 354 as seen from the distal end, and Figure 30 shows a perspective view of the drug delivery element 334 as seen from the proximal end.

[0272] The dispensing element 334 has a label 168 on its outer surface 421 indicating one of the settable dose settings. On its inner surface 422, the dispensing element 334 has a longitudinal groove for a connector 339 that connects to the driver 336 so as to be rotatably fixed and axially movable. The longitudinal groove engages with outward-facing ribs provided on the outer surface of the driver 336.

[0273] Figures 31 to 33 show the carrier 24 of the drug delivery member 323 of the first mechanism 354. The carrier 24 includes axial and rotational fixing means for fixing the carrier 24 to the drug delivery element 334 in the axial and rotational directions. The axial and rotational fixing means are provided at the proximal end of the carrier 24. The axial fixing means is configured as a radially extending opening 130, and the rotational fixing means is configured as an axially extending slot 132.

[0274] As shown in Figure 29, the drug delivery element 334 has an axially extending rib 134 configured to engage with a slot 132 of the carrier 24 to rotatably lock the drug delivery element 334 to the carrier 24. Furthermore, the drug delivery element 334 has a projection 136 having a chamfered surface 136a that engages with an opening 130 of the carrier 24. The opening 130 and projection 136 form an axial fixing means, while the slot 132 and rib 134 form a rotational fixing means. The axial and rotational fixing means allow the carrier 24 and the drug delivery element 334 to be connected to each other at one defined relative rotational position. To further enhance the rotational fixing between the carrier 24 and the drug delivery element 334, an axially extending rib 138 is formed on the inner surface of the carrier 24 (see Figure 33) that engages with an axially extending groove 140 (see Figure 29) on the outer surface of the drug delivery element.

[0275] The carrier 24 has an axial section on its outer surface having a reduced outer circumference that forms a coupling section 112 for the connector 26.

[0276] The carrier 24 further includes a counter element 116 of a dose-defining mechanism 115 that defines the rotational position of the drug delivery member 323 corresponding to a configurable dose. The counter element 116 is located on the outer surface of the carrier 24. It is exemplary configured as a radial projection extending in the axial direction. Furthermore, the counter element 116 forms an axially extending rib. The counter element 116 may have a symmetrical or asymmetrical cross-section in a radial plane perpendicular to the longitudinal axis of the first mechanism 354.

[0277] The counter element 116 is elastically fixed to the carrier 24. It is configured to flex radially. In this embodiment, the counter element 116 is located on an elastically deformable section 120 of the carrier 24. The elastically deformable section 120 is formed by an axially extending arm partially enclosed by a notch 121. The elastically deformable section 120 bends inward as the counter element 116 passes the dose stop section.

[0278] The carrier 24 further comprises a stopper 124. The stopper 124 extends radially from the outer surface of the carrier 24. The stopper 124 is configured as a hard stop. It is formed by axially extending ribs that extend along the longitudinal axis of the first mechanism 354. The stopper 124 is positioned at an axial distance from the counter element 116. Furthermore, it is aligned with the counter element 116 in the rotational and axial directions.

[0279] Furthermore, an additional first engaging portion 110 of the clutch 107 is located on the carrier 24. The additional first engaging portion 110 is configured as teeth projecting radially on the outer surface of the carrier 24. It is located at the distal end of the carrier 24. In this case, the radially projecting teeth cover only sections of the outer surface of the carrier 24, and these sections are separated by sections without teeth. In other embodiments, the teeth may also cover the entire circumference of the outer surface of the carrier 24.

[0280] Figures 34 to 37 show the connector 26 of the first mechanism 354. The connector 26 is constructed as a hollow, substantially cylindrical member. It has a longitudinal slit that extends along the entire length of the connector 26. The connector 26 has an open cross section along its entire longitudinal length. This allows the connector to be clipped onto the coupling section 112 of the carrier 24 during assembly of the first mechanism 354.

[0281] The connector 26 is axially fixed and connected to the carrier 24 in both directions by a connector 26 having an axial length corresponding to the axial length of the reduced circumference of the coupling section 112. At the same time, the connector 26 is rotatable relative to the carrier 24.

[0282] The connector 26 includes a first engaging portion 114 of the clutch 113. The first engaging portion 114 is configured as radially extending teeth located on the outer surface of the connector 26. Similar to the further first engaging portion 110 of the further clutch 107, the teeth of the first engaging portion 114 of the clutch 113 cover only the periphery section of the connector 26, and these sections are separated by sections without teeth. In other embodiments, the teeth may also cover the entire circumference of the outer surface of the connector 26.

[0283] The first engaging portion 114 is located at the distal end of the connector 26. At the proximal end, the connector 26 is provided with longitudinal ribs of the rotation lock 150.

[0284] Figures 38 to 41 show the dose setting element 22 of the first mechanism 354. The dose setting element 22 is configured as a substantially cylindrical element that extends longitudinally along the longitudinal axis of the first mechanism 354. Furthermore, it is configured as a hollow member.

[0285] The dose setting element 22 includes a second engaging portion 108 of the clutch 113. The second engaging portion 108 is configured as radially extending teeth arranged around the circumference of the cylindrical surface of the dose setting element 22. As a result, the second engaging portion 108 is located on the inner surface of the dose setting element 22. The teeth extend radially inward from the inner surface.

[0286] The dose setting element 22 also includes a further second engagement portion of the further clutch 107. Thus, the further second engagement portion is formed by the second engagement portion 108 of the clutch 113.

[0287] The dose setting element 22 includes a gripping surface 21 and radially projecting ribs 76 that extend in the axial direction on its outer surface. The ribs 76 form anti-roll features that prevent the first mechanism 354 from rolling when placed on a flat surface.

[0288] Figures 42–45 show the intermediate member 20 of the first mechanism 354, and Figures 46–50 show the button 318 of the first mechanism 354. The button 318 has a distal end face 80 for applying force to the button 318 to inject a set dose. The button 318 includes axial fixing means 82 for axially attaching the button 318 to the intermediate member 20, which is axially fixed to the dose setting element 22. The axial fixing means 82 includes two elastically deformable hooks 82 that engage with circumferentially extending ribs 84 on the intermediate member 20. The intermediate member 20 also includes axial fixing means 86 in the form of an elastically deformable, bendable hook that engages with an undercut 88 formed in the dose setting element 22. The button 318, the intermediate member 20, and the dose setting element 22 are permanently axially fixed to each other in the assembled state of the first mechanism 354. In other embodiments, the button 318 can also be axially fixed to the dose setting element 22 by other means. For example, the button 318 can directly engage with the dose setting element 22 without the intermediate member 20.

[0289] Button 318 also has a rotational fixing means 90 in the form of a radially extending rib. The rib 90 is geometrically engaged with the rotational fixing means 92 of the intermediate member 20, thereby the rotational fixing means 92 is formed, exemplary, as teeth positioned on the inner circumferential surface of the intermediate member 20. The rotational fixing means 90, 92 rotatably fix button 318 to the intermediate member 20. The rotational fixing means 92 of the intermediate member 20 forms a toothed portion 93 of the intermediate member 20, and the rib 90 forms an engaging portion of button 318. The intermediate member 20 includes a rotational fixing means 94 in the form of an axially extending recessed section that defines the side surface of an elastically deformable, bendable hook 86 and engages with the rotational fixing means 96 in the form of an axially extending rib on the inner circumferential surface of the dose setting element 22.

[0290] After and while assembled, the button 318, intermediate member 20, and dose setting element 22 are firmly connected to each other, forming the operating unit 316 of the mechanism 354.

[0291] The button 318 further has a cylindrical portion 18a. The cylindrical portion 18a is configured as a hollow member. It also forms the proximal portion of the button 318. In the first mechanism 354, the cylindrical portion 18a is formed integrally with the distal portion of the button 318 that forms the distal end face 80. In other embodiments, the portion forming the end face 80 and the cylindrical portion 18a may be configured as separate elements that are firmly connected to each other and fixed to each other in the axial and rotational directions.

[0292] The cylindrical portion 18a is where the first retainer element 98a of the retainer 97 is located. Furthermore, the cylindrical portion 18a also comprises a further first retainer element 98b.

[0293] As is best seen in Figures 48 and 50, the button 318 includes an axially extending rib 104 on its inner circumferential surface. The axially extending rib 104 engages with an axially extending groove 106 of the nut 38 to form a rotational lock 103. The rotational lock 103 allows the button 318 and the nut 38 to move axially relative to each other, but locks them rotationally relative to each other.

[0294] Figure 51 shows a subassembly of the first mechanism 354, which includes a piston rod guide 342, a dispensing member 323, a connector 26, and a button 318.

[0295] The first engaging portion 114 of clutch 113 and the further first engaging portion 110 of the further clutch 107 are located adjacent to each other. As a result, the first engaging portion 114 is located proximal to the further first engaging portion 110. When the first mechanism 354 is in the dose setting state, the actuation unit 316 having the button 318 and dose setting element 22 is in its distal position. The further second engaging portion 108 of the dose setting element 22 engages with the further first engaging portion 110 of the further clutch 107, thereby fixing the dose setting element 22 to the dispensing member 323 in the rotational direction.

[0296] When the first mechanism 354 transitions from the dose setting state to the dose administration state, the actuation unit 316 and button 318 move proximal. This disengages the further first and second engaging portions 108 and 110 of the further clutch 107, and engages the first engaging portion 108 and the second engaging portion 114 of the clutch 113. As a result, the dose setting element 22, which supports the first engaging portion 108, is rotatably fixed to the connector 26, which supports the second engaging portion. Consequently, the nut 38 is rotatably fixed to the piston rod 44.

[0297] Figure 52 shows a perspective view of the first embodiment of the dose selector 360 of the first mechanism 354 as seen from the distal end, and Figure 53 shows a perspective view of the first embodiment of the dose selector 360 as seen from the proximal end.

[0298] The dose selector 360 includes axial fixing means 142 in the form of a circumferentially extending projection on the inner surface 361 of the distal section of the dose selector 360. The dose selector 360 is axially fixed to the dose setting element 22 by inserting the distal section having the axial fixing means 142 into a circumferentially extending intake 144 of the dose setting element 22. At the intake 144, the dose setting element 22 has axial fixing means 146 in the form of a circumferentially extending projection on its outer surface, which engages with the axial fixing means 142 of the dose selector 360 to form an axial connection that allows relative rotational movement between the dose selector 360 and the dose setting element 22.

[0299] As can be seen in Figure 52, the rotational locking means 148, in the form of an axially extending groove, is located on the inner surface 361 of the dose selector 360. The rotational locking means 148 forms part of the rotational lock 150 between the dose selector 360 and the connector 26. Thus, the groove of the rotational locking means 148 engages with a projection of the rotational lock 150 formed on the outer surface of the connector 26. The rotational lock 150 allows axial movement between the dose selector 28 and the connector 26.

[0300] The dose selector 360 further includes axially extending ribs of a rotation lock 152 formed on the outer circumferential surface of the dose selector 360. The ribs of the rotation lock 152 engage with corresponding grooves formed on the inner circumferential surface of the housing 332. The rotation lock 152 is configured to define one single possible rotational alignment, thereby enabling insertion of the dose selector 360 into the housing 322.

[0301] As shown in Figure 53, the dose selector 360 includes a dose stop portion 118 of the dose definition mechanism 115 on its inner surface 361. The dose stop portion 118 is configured as a radial projection extending from the inner surface 361. In addition to the dose stop portion 118, the dose definition mechanism 115 includes a further dose stop portion 119 configured as disclosed for the dose stop portion 118. The dose stop portion 118 and the further dose stop portion 119 are located in the same axial position on the dose selector 360. They are spaced apart from each other in the circumferential direction. In other embodiments, the dose selector 360 may include only a single dose stop portion 118.

[0302] The circumferential positions of the individual dose stop units 118 and 119 relative to the housing 332 define the individual relative rotational positions of the drug delivery member 323 and the driver 336 relative to the housing 332, corresponding to the configurable doses.

[0303] When the first mechanism 354 is in the dose setting state, the dose stop section 118 of the dose definition mechanism 115 and the counter element 116 provided on the carrier 24 are axially aligned with each other along the longitudinal axis of the first mechanism 354. The counter element 116 then rotates past the individual dose stop sections 118, 119 and engages with each individual dose stop section 118, 119. While passing over one of the dose stop sections 118, 119, the counter element 116 flexes radially inward and snaps into place on the respective dose stop section 118, 119.

[0304] The first mechanism 354 further includes a zero-dose mechanism 450 that defines a zero-dose position for the drug delivery member 323 for which no dose is set. The zero-dose position also corresponds to the rotational position of the drug delivery member 323 relative to the housing 332, which the drug delivery member 323 assumes at the end of dose administration.

[0305] The zero-dose mechanism 450 includes a zero-dose stop section 126 located on the inner surface 361 of the dose selector 360. The zero-dose stop section 126 is formed by a longitudinal edge that protrudes radially inward from the inner surface 361.

[0306] The zero-dose stop section 126 is configured to engage with a blocking section 124 formed on the outer surface of the carrier 24. When the zero-dose position is reached, the blocking section 124 rotates into contact with the zero-dose stop section 126. This prevents further rotational movement of the dispensing member 323 relative to the housing 332.

[0307] The angular distance between the zero dose stop unit 126 and the individual dose stop units 118 and 119 defines the amount of individual doses of pharmaceutical corresponding to each dose stop unit 118 and 119.

[0308] The dial setting of intermediate doses between the individual dose stop units 118 and 119 is prevented by a spring 40 located between the piston rod guide 342 and the driver 336. The spring 40 is loaded when increasing the set dose, so that the dose setting element 22 is released and the counter element 116 on the carrier 24 is positioned between the two dose stop units 118 and 119, which rotates the dispensing member 323 back to the last set dose.

[0309] The dose selector 360 further includes a maximum dose stop section 128 of the maximum dose mechanism 440. The maximum dose stop section 128 is also located on the inner surface 361 of the dose selector 360. This is formed by a longitudinal edge that projects radially inward from the inner surface 361. Similar to the zero dose stop section 126, the maximum dose stop section 128 is configured as a hard stop.

[0310] The maximum dose mechanism 440 further includes a stopper 124 configured to engage with the maximum dose stopper 128 after the dial has been set beyond the maximum dose setting provided by a further dose stopper 119, as shown in the embodiments of Figures 52 and 53. Generally, the stopper 124 of the carrier 24 is configured to contact the maximum dose stopper 128 when the dispensing member 323 is rotated to a rotation position corresponding to or exceeding the maximum settable dose, thereby preventing further rotation of the dispensing member 323.

[0311] In the embodiments shown in Figures 52 and 53, the maximum dose stop unit 128 and the zero dose stop unit 126 are configured as opposing sides of a step located on the inner surface 361 of the dose selector 360.

[0312] The first mechanism 354 further includes a blocking mechanism 400 that prevents the transition of the first mechanism 354 from a dose-administering state to a dose-setting state during dose administration. The blocking mechanism 400 includes a first element 156 located in the dose selector 360 and a second element formed by a counter element 116 of the carrier 24.

[0313] The first element is configured as a rib 156 that extends longitudinally around the longitudinal axis of the first mechanism 354. It is located on the inner surface 361 of the dose selector 360. Furthermore, it is located distal to the dose stop sections 118, 119 and adjacent to the dose stop sections 118, 119.

[0314] Figure 54 shows a longitudinal cross-sectional view of the first mechanism 354 in the dose setting state, in a plane parallel to the longitudinal axis, passing through the carrier 24 of the dose selector 360 and the drug dispensing member 323. Figure 55 shows a longitudinal cross-sectional view of the first mechanism 354 in the dose administration state, in a plane parallel to the longitudinal axis, passing through the carrier 24 of the dose selector 360 and the drug dispensing member 323.

[0315] During dose setting, the counter element 116 is located 1 proximal to the rib 156. When the first mechanism 354 transitions from the dose setting state to the dose administration state, the dose selector 360 is moved 1 proximal to the drug delivery member 323. This causes the counter element 116 to move distally to the opposite side of the rib 156. Generally speaking, the counter element 116 is located on both sides of the rib 156 in both the dose administration state and the dose setting state.

[0316] The rib 156 is configured to allow the counter element 116 to move axially beyond the rib 156 when the first mechanism 354 transitions from a dose setting state to a dose administration state, and to prevent the counter element 116 from moving axially beyond the circumferential rib 156 during dose administration. For this purpose, the rib 156 includes, exemplary, an opening 158 located at the dose stop section 118, 119, which allows the counter element 116 to pass from one side of the rib 156 to the opposite side of the rib 156. Thereafter, the counter element 116 passes through the opening 158.

[0317] To prevent the counter element 116 from returning through the opening 158 towards the dose stop sections 118 and 119 when the button 318 is released, the rib 156 includes a recessed section 362 formed in the opening 158. The recessed section 362 extends radially inward on the inner surface 361 for a distance smaller than the radial range of the rib 156. The counter element 116 is configured to snap onto the recessed section 362 when the first mechanism 354 is transitioned from the dose setting state to the dose administration state, and to interfere with the recessed section 362 when the button 318 is released in the dose administration state. This prevents the counter element 116 from returning towards the dose stop sections 118 and 119.

[0318] As can be seen in Figures 54 and 55, each recessed section 362 includes a chamfered portion 364 facing the counter element 116 in the dose-setting state. The counter element 116 includes a corresponding chamfered portion 117. As the counter element 116 moves axially relative to the recessed section 362, the chamfered portions 117, 364 slide along each other, thus facilitating radial deflection of the counter element 116.

[0319] The rib 156 and the corresponding end face of the counter element 116, located axially opposite the chamfered portions 117, 364, are oriented perpendicular to the longitudinal axis and therefore do not feature chamfered portions. As can be seen from Figure 55, the counter element 116 is then blocked by the rib 156 when it moves in the proximal direction 1. In other embodiments, the rib 156 and the end face of the counter element 116, which engage to block the movement of the counter element 116 in the proximal direction 1 relative to the dose selector 360, can also be angled to deflect the counter element 116 radially outward. This further prevents the counter element 116 from disengaging from the rib 156 when the button 318 is released during dose administration.

[0320] In alternative embodiments, the rib 156 and the counter element 116 may include only one of the chamfered portions 117, 364, or neither of the chamfered portions 116, 364. Furthermore, the circumferential rib 156 may also not include the opening 158 located adjacent to the dose stop portions 118, 119. In these embodiments, the deflection of the counter element 116 during the transition of the first mechanism 354 from the dose setting state to the dose administration state may be caused by either or both of the chamfered portions 117, 364.

[0321] At the zero dose position, the rib 156 includes an opening 158 that does not feature a recessed section 362. This allows the counter element 116 to pass axially through the rib 156, and thus allows the first mechanism 354 to transition from the dose-administering state to the dose-setting state. In embodiments configured as a single-use mechanism, allowing the dose to be set and administered only once, the rib 156 may also not include the opening 158 at the zero dose position. This prevents the user from returning to the dose-setting state after setting and administering the first dose using the first mechanism 354. Alternative embodiments of the disposable device may also include coupling means that act between the button 318 and the dispensing member 323, axially locking the button 318 to the dispensing member 323 after the proximal movement of the button 318 to transition the first mechanism 354 from the dose-setting state to the dose-administering state. Such coupling means is described, among other things, in U.S. Patent Application No. 17 / 981231.

[0322] The axial movement of the counter element 116 relative to the dose stop units 118 and 119 during the transition of the first mechanism 354 from the dose setting state to the dose administration state also disengages the counter element 116 from the dose stop units 118 and 119. As long as the user presses the button 318 in the proximal direction 1, the dispensing member 323 can rotate freely and return to the zero dose position, and the set dose is automatically administered by the force stored in the spring 40.

[0323] The first mechanism 354 also includes a break 390 configured to stop the movement of the nut 38 and piston rod 44 when the apartment 318 is released during dose dispensing. The brake 390 includes a first break formed by the rib 156 and a second break formed by the counter element 116.

[0324] During dose administration, the counter element 116 rotates around the rib 156 to return to the zero dose position. When the button 318 is released during dose administration, the biasing element 250 biases the rib 156 provided on the dose selector 360 toward the counter element 116 on the carrier 24. This causes the engaging section 392 of the counter element 116 to press against the fracture surface 366 of the rib 156. Thus, the engaging section 392 is formed by the proximal end face of the counter element 116, and the fracture surface 366 is formed by the distal end face of the rib 156.

[0325] As can be seen in Figure 53, the rib 156 has a plurality of grooves 367 formed on the fracture surface 366. When the button 318 is released during dose administration, the counter element 116 engages with one of the grooves 367. This locks the drug dispensing member 323 into the dose selector 360 by shape fitting.

[0326] In an alternative embodiment, the rib 156 may not have groove 367. The drug dispensing member 323 can then be engaged with the dose selector 360 by friction locking.

[0327] Other embodiments of the first mechanism 354 do not require the brake 390. In these embodiments, the autoinjection continues even after the button 318 is released during dose administration.

[0328] Figure 56 shows a radial cross-section perpendicular to the longitudinal axis through the dose selector 360 having dose stop units 118, 119 and a carrier 24 for the drug delivery member 323. Thus, the first mechanism 354 is in a dose setting state where the drug delivery member 323 is in the zero dose position. The blocking unit 126 then contacts the zero dose stop unit 126.

[0329] To reduce the force required to rotate the dose setting element 22 and carrier 24 relative to the dose selector 360 to increase or decrease the set dose, the dose stop units 118, 119 have chamfered sides 122 and 123. According to the embodiment shown in Figure 56, the dose stop units 118, 119 have an asymmetrical cross-section in the radial plane perpendicular to the longitudinal axis of the first mechanism 354. Thereafter, the first side 122 that contacts the counter element 116 when the set dose increases has a smaller pitch than the second side 123 that contacts the counter element 116 when the dose decreases. In this case, the second side 123 also generates a larger reaction force than the first side 122. This helps prevent the dispensing member 323 from rotating back to the zero dose position due to the torque of the spring 40. In other embodiments, the first side 122 and the second side 123 may be symmetrical and have equal pitches to each other.

[0330] The embodiment of the dose selector 360 shown in Figures 52 to 66 is the first embodiment of the dose selector 360.

[0331] Figure 57 shows a bottom view of a second embodiment of the dose selector 360 from the proximal end. The dose selector 360 includes only a single dose stop section 118. Furthermore, the rib 156 does not feature a recessed section 362 in the opening 158 formed in the dose stop section 118. Furthermore, the maximum dose stop section 128 is located immediately adjacent to the dose stop section 118. Finally, the first side surface 122 and the second side surface 123 are symmetrical and have equal pitch to each other.

[0332] Figure 58 shows a bottom view of a third embodiment of the dose selector 360 from the proximal end. The dose selector 360 includes four dose stop sections 118, 119. The dose stop section 118 is configured as an asymmetric dose stop section having a first side surface 122 having a smaller angle than a second side surface 123. Furthermore, the dose selector 360 does not feature an opening 158 at the zero dose position adjacent to the zero dose stop section 126. This prevents the first mechanism 354 from returning from the dose administration state to the dose setting state at the end of dose administration. The first mechanism 354 is then configured as a disposable mechanism.

[0333] Figure 59 shows a top view of a first embodiment of the dose selector 360 from the distal end. As can also be seen from Figure 52, the first mechanism includes a feedback mechanism 410 that indicates the end of dose administration. The feedback mechanism 410 is configured to provide the user of the device with audible and / or haptic feedback.

[0334] The feedback mechanism 410 includes a counter element 116 and a feedback element 368. At the end of injection, the counter element 116 passes over the feedback element 368 and flexes radially inward. When disengaged from the feedback element 368, the counter element 116 relaxes radially outward, producing an audible and / or perceptible click.

[0335] The feedback element 368 is located next to the zero-dose stop unit 126. It is configured as a slope with a shallow side facing away from the zero-dose stop unit and a steep side facing towards the zero-dose stop unit. When returning to the zero-dose position, the counter element 116 gradually flexes as it moves over the shallow side. The counter element 116 then rapidly moves over the steep side, thereby generating audible and / or tactile feedback.

[0336] The first mechanism 354 firmly connects the dose setting element 22 and the button 318 of the actuation unit 316, fixing them to each other in the axial and rotational directions. In other embodiments, the dose setting element 22 and the button 318 may also be movable relative to each other.

[0337] In alternative embodiments, the rib 156 may also be engaged by the blocking portion 124 of the carrier 24. The rib 156 can then be positioned proximal to the dose stop portions 118, 119. In these embodiments, the opening 158 does not include the recessed section 362.

[0338] In all embodiments of the dose selector 360, individual dose stop units can be configured as symmetric or asymmetric dose stop units. Additionally or alternatively, the dose stop units may be at equal and / or unequal distances from each other in the circumferential direction. Thus, the set distance of each dose stop unit from the zero dose position of the counter element may be equal to an integer multiple of a dose step, such as an integer multiple of the minimum set distance of a first dose stop unit that defines the minimum settable dose. Alternatively, the set distance of at least one dose stop unit, for example all dose stop units, may be different from an integer multiple of the minimum set distance.

[0339] The first mechanism 354 restricts the dispensing member 323 to perform less than one rotation around its longitudinal axis during dose setting. In other embodiments, the dispensing member 323 may also be capable of performing at least one full rotation or two or more full rotations during dose setting. In these embodiments, the first mechanism 354 may not feature a zero-dose mechanism 450 and / or a maximum-dose mechanism 440. A minimum-dose stop mechanism may then be configured between the driver 336 and the housing 332, for example, between the driver 336 and the piston rod guide 342. A maximum-dose stop mechanism may then be configured between the driver 336 and the dispensing member 323, for example, between the driver 336 and the dispensing element 334. The maximum-dose stop mechanism can then restrict the relative axial movement of the driver 336 with respect to the dispensing member 323.

[0340] Figure 60 shows a cross-sectional view of the second mechanism 610 for the automated drug dispensing device according to this disclosure in the dose setting state before setting the dose. Unless otherwise disclosed, the second mechanism 610 is configured as disclosed for the first mechanism 354, and vice versa.

[0341] The second mechanism 610 allows the button 318 to move axially relative to the dose setting element 22. Furthermore, the button 318 is rotatably fixed to the dose setting element 22. The axial lock 510 acts between the button 318 and the dose setting element 22, rotatably locking the button 318 to the dose setting element 22 while allowing relative axial movement. In an exemplary configuration, the axial lock 510 may be configured as a spline connection having interacting longitudinal ridges and grooves. The axial lock 510 can be formed on the dose setting element 22 and the button 318. Alternatively, the axial lock 510 can be formed on one or more intermediate members located between the button 318 and the dose setting element 22.

[0342] The dose setting element 22 is axially fixed to the housing 332 of the second mechanism 610. Furthermore, the dose setting element 22 is rotationally movable relative to the housing 332. The dose setting element 22 is connected to the housing 332 by an axial locking 535 that prevents relative rotational movement between the dose setting element 22 and the housing 332 and allows relative axial movement. The axial locking 535 may be located at the distal end of the housing 332. Additionally or alternatively, the axial locking 535 may be located at the proximal end of the dose setting element 22. The axial locking 535 may be configured, exemplary, as a snap-fit ​​connection. For example, the axial locking 535 may be configured as described for an axial locking having axial fixing means 142, 146 between the dose setting element 22 and the dose selector 360 of the first mechanism 354.

[0343] The carrier 24 of the drug dispensing member 323 is rotatably fixed to the drug dispensing element 334 of the drug dispensing member 323 and is movable in the axial direction. The rotation lock 520 acts between the carrier 24 and the drug dispensing element 334, rotatably fixing the carrier 24 to the drug dispensing element 334. The rotation lock 520 may be configured as a spline connection having a longitudinal ridge and a corresponding longitudinal groove that engages with the longitudinal ridge. In other embodiments, the rotation lock 520 may also be configured as a contiguous non-circular cross-section of two locking elements of the rotation lock 520 that engage with each other.

[0344] The rotation lock 520 can be formed by the carrier 24 and the dispensing element 334. In an alternative embodiment, the rotation lock 520 may be formed by one or more intermediate members coupled between the carrier 24 and the dispensing element 334.

[0345] Similar to the first mechanism 354, the drug delivery element 334 of the second mechanism 610 is rotationally movable relative to the housing 332 and fixed axially. Thereafter, the blocker 430 axially restrains the drug delivery element 334 distally, as disclosed in relation to the first mechanism 354.

[0346] The carrier 24 of the medication dispensing member 323 is fixed axially to the button 318 and movable in the rotational direction. An axial locking mechanism 530 acts between the carrier 24 and the button 318, preventing relative axial movement while allowing relative rotational movement. The axial locking mechanism 530 can be formed by the carrier 24 and the button 318. In an alternative embodiment, the axial locking mechanism 530 can be formed by one or more intermediate members coupled between the carrier 24 and the button 318. For example, one of these intermediate members may be fixed axially and / or rotationally to the button 318.

[0347] The axial locking 530 is exemplary formed by two radially extending portions of a button 318, which are axially spaced apart from each other to form an axially confined section, and within this axially confined section the carrier 24 is received.

[0348] In the embodiment shown in Figure 60, the button 318 includes a substantially cylindrical proximal portion configured as a hollow cylinder. The carrier 24 is then positioned around the outer surface, i.e., the outer circumferential surface, of the cylindrical proximal portion. The cylindrical proximal portion can be formed integrally with the distal portion of the button 318, including the end face 80. In an alternative embodiment, the cylindrical proximal portion may be formed as a separate part from the distal portion, and the cylindrical proximal and distal portions may be configured to be joined axially and fixed rotationally during assembly. For example, the distal and proximal portions may be configured to be joined after the carrier 24 is positioned around one of the distal and proximal portions.

[0349] The button 318 receives a nut 38 that is axially movable and rotationally fixed within its proximal portion, as described for the cylindrical portion 18a of the button 318 of the first mechanism 354.

[0350] The second mechanism 610 includes a dose selector 540 fixed axially and rotationally to the housing 332. Unless further differences are disclosed, the dose selector 540 is configured as disclosed for the dose selector 360 of the first mechanism 354.

[0351] The dose selector 540 is exemplary formed integrally with the housing 332. In other embodiments, the dose selector 540 may also be configured as a separate component that is fixed to the housing 332 in the rotational and axial directions during the assembly of the second mechanism 610.

[0352] As can be seen from Figure 60, the rib 156, which forms part of the brake 390 and the blocking mechanism 400, is located proximal to the counter element 116. In the second mechanism 610, the interaction between the counter element 116 and the components 118, 119, 156, 362, 367, and 368 located on the inner surface 361 of the dose selector 540, and the relative movement of the counter element 116 with respect to these components, occurs in the same way as described in relation to the first mechanism 354, except that the axial direction of the movement is reversed.

[0353] A clutch 113 that locks the nut 38 to the piston rod 44 in the rotational direction during dose administration operates between the button 318 and the housing 332. The first engaging portion 561 of the clutch 113 is fixed to the housing 332 in the axial and rotational directions. It may be formed integrally with the housing 332 or attached to the housing 332 as a separate part. The second engaging portion 562 of the clutch 113 is fixed to the button 318 in the axial and rotational directions. It may be formed integrally with the button 318 or attached to the button 318 as a separate part. The first engaging portion 561 and the second engaging portion 562 are disengaged from each other in the dose setting state shown in Figure 60.

[0354] A further clutch 107 that rotatably secures the dose setting element 22 to the dispensing member 323 during dose setting acts between the dose setting element 22 and the carrier 24, as disclosed for the clutch 107 of the first mechanism 354. Thus, the dose setting element 22 includes, exemplary, a further second engaging portion 566 of the further clutch 107, and the carrier 24 includes, exemplary, a further first engaging portion 565 of the further clutch 107. As disclosed for the further clutch 107 of the first mechanism 354, the further first and second engaging portions of the further clutch 107 of the second mechanism 610 can be configured as longitudinal teeth extending radially. The further first engaging portion 565 may be formed integrally with the carrier 24 or may be attached to the carrier 24 as a separate part fixed in the axial and rotational directions. Similarly, the additional second engagement portion 566 may be integrally formed with the dose setting element 22, or it may be attached to the dose setting element 22 as a separate portion fixed in the axial and rotational directions.

[0355] In the dose setting state shown in Figure 60, the further first engaging portion 565 engages with the further second engaging portion 566, and the further clutch 107 is in its closed state, which rotationally locks the dose setting element 22 to the drug dispensing member 323 and the driver 336.

[0356] During dose setting, the rotation of the dose setting element 22 is transmitted to the nut 38 via the rotation lock 510 and the button 318. Furthermore, the rotation of the dose setting element 22 is transmitted to the driver 336 and the spring 40 via a closed additional clutch 107, the carrier 24, the rotation lock 520, and the dispensing element 334.

[0357] In the second mechanism 610, a stopper 373 that restricts the proximal movement of the button 318 during dose administration acts between the dose setting element 22 and the button 318. Thus, it acts directly between the dose setting element 22 and the button 318, with the dose setting element 22 forming a first stopper of the stopper 373 and the button 318 forming a second stopper. The stopper 373 is exemplary located on the dose setting element 22 and is configured to engage with the button when the button 318 moves proximal.

[0358] In other embodiments, the stop unit 373 may also act directly between the button 318 and the housing 332, or between the button 318 and the dispensing element 334.

[0359] Figure 61 shows a cross-sectional view of the second mechanism 610 in the dose setting state after the dose has been set by rotating the dose setting element 22 relative to the housing 332. Both the clutch 38 and the driver 336 have moved distally, so that the rotation of the driver 336 deforms the spring 40 and stores energy in the spring 40. The clutch 38 has moved by a dose distance 3.

[0360] Figure 62 shows a cross-sectional view of the second mechanism 610 in the dose-administering state before administering the set dose. Button 318 is moved in the proximal direction 1 until the stop 373 restricts further proximal movement. Button 318 then engages with the stop 373.

[0361] The proximal movement of button 318 also moves carrier 24 in the proximal direction 1. As a result, the further first engaging portion 565 of the further clutch 107 is disengaged from the further second engaging portion 566 by relative axial movement toward each other. The dispensing member 323 then rotates freely relative to housing 332.

[0362] The axial movement of the button 318 further closes the clutch 113 so that the first engaging portion 561 engages with the second engaging portion 562. This locks the button 318 in the rotational direction to the housing 332, and therefore the nut 38 also locks to the piston rod 44.

[0363] The counter element 116 is moved from the distal side of the rib 156 to the proximal side of the rib 156. Proximal to the rib 156, the rib 156 includes a fracture surface 366 that interacts with the counter element 116 when the button 318 is released during dose administration. The dose stop sections 118 and 119 are located distal to the rib 156, and the feedback element 368 is located proximal to the rib 156.

[0364] Generally speaking, the fracture surface 366 and the dose-relieving sections 118 and 119 are located on the opposite side of the rib 156 in the longitudinal direction.

[0365] Figure 63 shows a cross-sectional view of the second mechanism 610 in the dose-administering state after the set dose has been administered. Driven by the spring 40, the driver 336 and nut 38 are moved proximal 1 by a dose distance 3. The piston rod 44 is also moved proximal 1 by a dose distance 3 due to an axially fixed connection between the nut 38 and the piston rod 44. The rotation of the driver 336 during dose administration rotates the carrier 24 back to its zero-dose position, thereby transmitting torque to the carrier 24 via the drug delivery element 334 and the rotation lock 520.

[0366] Similar to the first mechanism 354, the second mechanism 610 may include a biasing member that biases the button 318 distally relative to the housing 332.

[0367] Figure 64 shows the third mechanism 620 for the automated drug dispensing device according to this disclosure in the dose-setting state before dose setting, and Figure 65 shows the third mechanism 620 in the dose-administering state after dose dispensing. Unless otherwise disclosed, the third mechanism 620 is configured as disclosed for the second mechanism 610, and vice versa.

[0368] The stop portion 373 of the second mechanism 610 is located on the inner surface of the dose setting element 22, while the stop portion 373 of the third mechanism 620 is located at the distal end of the dose setting element 22. This is, exemplary, formed by the distal end face of the dose setting element 22. In the dose-administering state, the button 318 is oriented radially outward and is configured to contact the stop portion 373 with a radial projection located at the distal end of the button 318.

[0369] The third mechanism 620 also includes a retainer 96 that prevents the button 318 from coming off the housing 332. The retainer 96 acts between the medication member 323 and the button 318, i.e., between the medication element 334 and the button 318. The first retainer element 621 is fixed to the button 318, and the second retainer element 622 of the retainer 97 is fixed to the medication member 323, i.e., the medication element 334. The first retainer element 621 is exemplary located at the proximal end of the button 318, and the second retainer element 622 is exemplary located at the distal end of the medication element 334.

[0370] In the dose setting state shown in Figure 64, the first retainer element 621 and the second retainer element 622 are engaged with each other in the axial direction, while in the dose administration state shown in Figure 65, the first retainer element 621 moves axially away from the second retainer element 622.

[0371] In an alternative embodiment, the stopper 373 of the third mechanism 620 may also be configured as the stopper 373 of the second mechanism 610.

[0372] Figure 66 shows a cross-sectional view of the fourth mechanism 630 for the automated drug dispensing device according to this disclosure in the dose-setting state before setting the dose, and Figure 67 shows a cross-sectional view of the fourth mechanism 630 in the dose-administering state after administering the set dose. Unless otherwise disclosed, the fourth mechanism 630 is configured as disclosed for the third mechanism 620, and vice versa.

[0373] In the fourth mechanism 630, a further clutch 107 is coupled to the dose setting element 22 via a button 318, which rotatably engages the dose setting element 22 with the medication dispensing member 323. The further clutch 107 is exemplary formed between the medication dispensing member 323 and the button 318. A further first engaging portion 565 is fixed to the medication dispensing member 323, and a further second engaging portion 566 is fixed to the button 318. In the embodiments shown in Figures 66 and 67, the further first engaging portion 565 is fixed to the medication dispensing element 334. The further second engaging portion 566 is exemplary located at the proximal end of the button 318. Furthermore, a further clutch 107 is located within the medication dispensing member 323, i.e., within the medication dispensing element 334.

[0374] In the fourth mechanism 630, the force exerted by the user when rotating the dose setting element 22 during dose setting is transmitted to the drug dispensing member 323 and driver 336 via the rotation lock 510, button 318, and further clutch 107. The axial distance that button 318 travels when transitioning from the dose setting state to the dose administration state in the fourth mechanism 630 is reduced compared to the second and third mechanisms 610 and 620.

[0375] Figure 68 shows a cross-sectional view of the fifth mechanism 640 for the automated drug dispensing device according to this disclosure in the dose-setting state before setting the dose, and Figure 69 shows a cross-sectional view of the fifth mechanism 640 in the dose-dispensing state after dispensing the set dose. Unless otherwise disclosed, the fifth mechanism 640 is configured as disclosed with respect to the fourth mechanism 630, and vice versa.

[0376] The fifth mechanism 640 includes a dose selector 550 that is axially movable relative to the housing 332 and fixed in the rotational direction. Thereafter, the dose selector 550 is coupled to the housing 332 by a rotational lock 554 that prevents relative rotation and allows axial movement between dose selectors 550 within the housing 332. The rotational lock 554 can be configured as a spline connection, similar to the rotational lock 152 between, for example, the dose selector 360 and the housing 332 of the first mechanism 354. Unless further differences are disclosed, the dose selector 550 is configured as disclosed for the dose selector 360 of the first mechanism 354, and vice versa.

[0377] The dose selector 550 is fixed axially to the button 318, is rotationally movable, and is coupled to the button 318 via an axial locking mechanism 552. The axial locking mechanism 552 is formed between the dose selector 550 and the button 318. In an alternative embodiment, the axial locking mechanism 552 may also be formed on one or more intermediate members.

[0378] Generally, the dose selector 550 can be configured to follow the axial movement of the button 318. In some embodiments, the dose selector 550 can then contact the button 318 only, for example, in the distal direction. In addition, the dose selector 550 can be biased distally by a biasing element acting, for example, between the dose selector 550 in the housing 332 or between the dispensing member 332 and the dose selector 550. The biasing element can be located, for example, within the dose selector 550. It may be configured, for example, as a compression spring. When the button 318 is moved in the proximal direction 1, it pushes the dose selector 550 and moves it against a biasing force directed distally.

[0379] The carrier 24 of the drug delivery member 323 is fixed to the drug delivery element 334 in an axial and rotatable manner. The carrier 24 and drug delivery element 334 of the fifth mechanism 640 can be configured as disclosed for the carrier 24 and drug delivery element 334 of the first mechanism 354. Furthermore, the layout of elements on the inner surface of the dose selector 550 of the fifth mechanism 640 can correspond to the layout of elements on the inner surface of the dose selector 360 of the first mechanism 354.

[0380] In an alternative embodiment of the fifth mechanism 640, the stop unit 373 can also act between the dose selector 550 and the housing 332, as described for the stop unit 373 of the first mechanism 354. Furthermore, the additional clutch 107 of the fifth mechanism 640 may be configured similarly to the additional clutch 107 of the second and third mechanisms 610, 620.

[0381] Figure 70 shows a detailed cross-sectional view of the distal portion of the sixth mechanism 650 according to this disclosure. Unless otherwise disclosed, the sixth mechanism 650 is configured as disclosed for the first mechanism 354.

[0382] In the sixth mechanism 650, the dose setting element 22 is fixed axially to the housing 332, and the button 318 is movable axially relative to the dose setting element 22. As can be seen in Figure 70, the outer housing 333 of the housing 332 extends distally to the dose setting element 22. The dose setting element 22 is connected to the housing 332 by an axial locking 510 that fixes the dose setting element 22 to the housing 332 while allowing relative rotational movement between the dose setting element 22 and the housing 332. The axial locking 510 can be configured as disclosed for the axial locking 510 of the second mechanism 610.

[0383] In this embodiment, the axial locking 510 is configured as disclosed for the axial fixing means 142, 146 between the dose setting element 22 and the dose selector 360 of the first mechanism 354. The dose setting element 22 includes the axial fixing means 142, which is exemplary configured as a circumferentially extending projection on the dose setting element 22. The circumferentially extending projection extends radially outward from the outer cylindrical surface of the dose setting element 22. The housing 332 includes the axial fixing means 146, which is configured as a circumferentially extending projection. The projection extends radially inward and is located on the inner cylindrical surface of the housing 332.

[0384] In other embodiments, the projections 146 may be located on the outer surface of the housing 332, for example, on the outermost surface of the housing 332. They may project radially outward. The projections 142 may also be located on the inner cylindrical surface of the dose setting element 22. The projections 142 may then project radially inward.

[0385] The button 318 extends axially distally from the dose setting element 22. It is raised distally by the biasing member 250.

[0386] The button 318 is connected to the dose setting element 22 by a rotation lock 510. The rotation lock 510 prevents relative rotation and allows relative axial movement between the dose setting element 22 and the button 318. The rotation lock 510 may be configured as disclosed for the rotation lock 510 of the second mechanism 610 and the third mechanism 620.

[0387] The dose selector 360 is fixed axially to the button 318 and movable in the rotational direction. It is connected to the button 318 by an axial locking 552. The axial locking 552 is exemplary formed on the dose selector 360 and the button 318. It includes a circumferential projection 653 located on the outer surface of the button 318 and extending radially outward. Furthermore, the axial locking 552 includes a circumferential projection 654 located on the inner surface of the dose selector 360 and extending radially inward. The circumferential projection 653 and projection 654 engage with each other to prevent distal axial movement of the button 318 relative to the dose selector 360. They are configured to snap into place with each other when the mechanism 650 is assembled. The circumferential projection 654 can be configured as disclosed for the circumferential projection 142 of the dose selector 360 of the first mechanism 354, and vice versa. The circumferential projection 654 can be configured as disclosed for the circumferential projection 146 of the dose setting element 22 of the first mechanism 354.

[0388] Additionally or alternatively, the axial locking 552 may be configured as disclosed for the axial locking 552 of the fifth mechanism 640.

[0389] In general, the details of the teachings for the rotational lock 510, axial lock 535, and axial lock 552 are for illustrative purposes only and do not constitute an essential feature of the present disclosure.

[0390] Similar to the dose selector 550 of the fifth mechanism 640, the dose selector 360 of the sixth mechanism 650 is located entirely within the sixth mechanism 650. The dose selector 360 is not accessible from the outside of the sixth mechanism 650.

[0391] In the sixth mechanism 650, the clutch 113, which rotatably secures the nut 38 to the piston rod 44 during dose administration, is located between the button 318 and the connector 26. The first engaging portion 114 of the clutch 113 is fixed to the housing 332 in the axial and rotatably directions. Furthermore, it is fixed to the drug delivery member 323 and the connector 26 in the axial and rotatably directions. In exemplary embodiments, the first engaging portion 114 is formed on the connector 26 as disclosed for the first mechanism 354. The second engaging portion 651 of the clutch 113 is fixed to the button 318 in the axial and rotatably directions. This is exemplary formed on the button 318. In other embodiments, it can be formed on an intermediate member fixed to the button 18 in the axial and rotatably directions. The first engaging portion 114 and the second engaging portion 651 can be configured as disclosed for the first engaging portion 114 and the second engaging portion 108 of the clutch 113 of the first mechanism 354.

[0392] A further clutch 107, which fixes one end of the spring 40 to the dose setting element 22 during dose setting and detaches the end from the dose setting element 22 during dose administration, is coupled to the dose setting element 22 via a button 318. In the embodiment shown in Figure 70, the further clutch 107 is exemplary formed between the button 318 and the drug dispensing member 323, i.e., between the button 318 and the carrier 24 of the drug dispensing member 323.

[0393] A further first engagement portion 110 of the further clutch 107 is fixed to the dispensing member 323 in the rotational and axial directions. It may be configured as disclosed for the further first engagement portion 110 of the further clutch 107 of the first mechanism 354. A further second engagement portion of the further clutch 107 is fixed to the button 318 in the axial and rotational directions. In the embodiment shown in Figure 70, the further second engagement portion of the further clutch 107 is formed by the further second engagement portion 651 of the clutch 113. A further second engagement portion of the further port 107 may be configured as disclosed for the further second engagement portion 108 of the further clutch 107 of the first mechanism 354.

[0394] An embodiment of the sixth mechanism 650 shown in Figure 70 includes a stopper 374 that restricts the proximal movement of the button 318, as described in relation to the first mechanism 351. The stopper 374 interacts with the housing 332 via the dispensing member 323. In an alternative embodiment, the sixth mechanism 615 may also include an embodiment of a stopper that interacts with the housing 332 via a dose setting element 22. This stopper may be configured as disclosed for any of the stoppers 373 of the second, third, fourth, and fifth mechanisms 610, 620, 630, and 640. In particular, the first stopper portion of the axial stopper can be formed by the distal surface of the dose setting element 22. The distal surface may be located at the distal end of the dose setting element 22, or located within the dose setting element 22, and may be away from the distal end of the dose setting element 22. The second stopper can be formed by the proximal surface of the button 318.

[0395] Figure 71 shows a cross-sectional view of the seventh mechanism 660 according to this disclosure in a cross-section parallel to the longitudinal axis where no dose is set, and Figure 72 shows a cross-sectional view of the seventh mechanism 660 in a cross-section parallel to the longitudinal axis where a maximum dose is set. Unless otherwise disclosed, the seventh mechanism 660 is configured as disclosed for the first mechanism 354, and vice versa.

[0396] The seventh mechanism 660 comprises a driver 670. Unless otherwise disclosed, the driver 670 is configured as disclosed for the driver 336 of the first mechanism 354. Furthermore, the seventh mechanism 660 includes a drug delivery member 680. Unless otherwise disclosed, the drug delivery member 680 is configured as disclosed for the drug delivery member 323 of the first mechanism 354.

[0397] Figures 73–75 show the drug delivery member 680, and Figure 76 shows the driver 670. The drug delivery member 680 includes a drug delivery element 681 located at the proximal end of the drug delivery member 680 and a carrier 685 located at the distal end of the drug delivery member 680. Unless otherwise disclosed, the carrier 685 is configured as disclosed for the carrier 24 of the first mechanism 354, and vice versa, and the drug delivery member 680 is configured as disclosed for the drug delivery member 334 of the first mechanism 354, and vice versa. The carrier 685 and the drug delivery member 680 are formed as a single, materially homogeneous piece. In other embodiments, the carrier 685 and the drug delivery member 680 may also be configured as two pieces fixed axially and rotationally to each other, as disclosed for the carrier 24 and drug delivery element 334 of the first mechanism 354.

[0398] In the seventh mechanism 660, the driver 670 protrudes into the carrier 685. Thus, the distal portion 671 of the driver 670 protrudes into the carrier 685. The driver 670, exemplary, the distal portion 671 of the driver 670, is located between the carrier 685 and the cylindrical portion 18a connected to the button 318. Both the first mechanism 354 and the seventh mechanism 660 cause the cylindrical portion 18a to connect the nut 38 to the button 318 and, exemplary, to directly engage with the nut 38. Using both the first and seventh mechanisms 354, 660, the nut connector is formed substantially uniformly with the button 318. In other embodiments, the nut connector may also form separate portions fixed axially and rotationally to the base 318.

[0399] As can be seen in Figure 76, the driver also has a proximal portion 674 or threaded portion that carries the male threads of the drive screw thread 337. The proximal portion 674 and the distal portion 671 are formed as a single, materially uniform portion.

[0400] The rotation lock 662 acts between the driver 670 and the drug dispensing member 680, thereby locking the driver 670 to the drug dispensing member 618 in the rotational direction. This allows the driver 670 to move axially relative to the drug dispensing member 680. The driver 670 engages with the drug dispensing member 680 via the rotation lock 662. As can be seen in Figure 76, the rotation lock 662 includes a longitudinal feature 672 of the driver 670. Furthermore, the rotation lock 662 includes a corresponding longitudinal feature 683 of the drug dispensing member 680, as shown in Figure 75. The longitudinal features 672 and 683 engage with each other, thereby locking the driver 672 to the drug dispensing member 680 in the rotational direction. One of the longitudinal features 672 and 683 is configured as a longitudinal ridge, and the other of the longitudinal features 672 and 683 is configured as a corresponding longitudinal groove. As a result, the longitudinal ridge is provided on the drug dispensing member 680, and the longitudinal groove is provided on the driver 670. Furthermore, the longitudinal feature 672 of the driver 670 is provided on the outer surface of the driver 670, that is, on the outer surface of the distal portion 671 of the driver 670. The longitudinal feature 683 of the drug dispensing member 680 is provided on the inner surface of the drug dispensing member 680, that is, on the inner surface of the carrier 685.

[0401] As can be seen in Figure 72, the driver 670 moves into the annular space formed between the drug delivery member 680 and the nut connector 18a as the set dose is increased. Compared to the first mechanism 354, this expands the dose distance 3, which allows the nut 38 and the driver 670 to move distally as the dose is set.

[0402] In the seventh mechanism 660, the drug delivery member 680 does not extend proximal 1 to the proximal outer body 387 of the piston rod guide 342. The proximal movement of the drug delivery member 680 is limited by a proximal stop 694 provided on the outer housing 690 of the seventh mechanism 660, as shown in Figure 77. Unless otherwise disclosed, the outer housing 690 is configured as disclosed for the outer housing 333 of the first mechanism 354, and vice versa.

[0403] The proximal stop portion 694 is configured as a distal opposing surface. It is formed substantially uniformly with the outer housing 690. Exemplarily, the proximal stop portion 694 is configured as a circumferential projection on the inner surface of the outer housing 690. Thus, the proximal stop portion 694 forms a closed ring-shaped projection.

[0404] A blocker 430, which prevents the button 318 from disengaging from the housing 332, is formed as a proximal opposing surface of the outer housing 690. The blocker 430 engages with a stop surface 682 of the dispensing member 680. Similar to the dispensing member 323 of the first mechanism 354, the stop surface 682 is configured as a distal opposing surface. It is formed, exemplary, as the surface of the dispensing element 681.

[0405] Although not shown in Figure 77, the seventh mechanism 660 may also include a stopper 373 that restricts the proximal movement of the button 318 during dose administration. Similar to the first mechanism 354, the stopper 373 may be configured to prevent the force exerted on the button 318 by the user from being transmitted to components of the seventh mechanism 660 that move relative to the housing 332 during dose administration. Similar to the first mechanism 354, the stopper 373 may act directly between the housing 332 and the button 318. The stopper 373 acting directly between the housing 332 and the button 318 means that the button 318 or a member firmly connected to the button 318 engages with the stopper 373.

[0406] Figure 78 shows a side view of a further drug delivery device in a dose-setting state, and Figure 79 shows a side view of a further drug delivery device in a dose-delivery state. The further drug delivery device comprises an eighth mechanism 700 according to this disclosure and a container holder 305 attached to the eighth mechanism 700. Unless otherwise disclosed, the eighth mechanism 700 is configured as disclosed for the first mechanism 354, and vice versa.

[0407] The eighth mechanism 700 has a housing 332 comprising an outer housing 730, and an actuation unit 316 connected to the distal end of the housing 332. The actuation unit 316 includes a button 318 and a dose setting element 22, which are firmly connected to each other and fixed to each other in the axial and rotational directions.

[0408] Figure 80 shows a cross-sectional view of the eighth mechanism 700 in a dose setting state where no dose has been set, in a cross-section parallel to the longitudinal axis. Figure 81 shows a cross-sectional view of the eighth mechanism 700 in a dose setting state where the maximum dose has been set, and Figure 82 shows a cross-sectional view of the eighth mechanism 700 in a dose administration state before administering the maximum dose.

[0409] The eighth mechanism 700 includes a driver 720 and a dispensing element 740. Unless otherwise disclosed, the driver 720 is configured as disclosed for the driver 336 of the first mechanism 354, and vice versa, and the dispensing element 740 is configured as disclosed for the dispensing element 334 of the first mechanism 354, and vice versa. The eighth mechanism 700 fixes the driver 720 and the dispensing element 740 to each other in the axial and rotational directions. They are exemplary formed as a single materially uniform part. In other embodiments, they may also be formed as two separate parts fixed to each other in the axial and rotational directions. The driver 720 is screwed to the housing 332 via a drive thread 337, as described in relation to the first mechanism 354.

[0410] The drug dispensing member 323 of the eighth mechanism 700 is configured as a coupler 710. The drug dispensing member 323 is fixed axially to the housing 332 and movable in the rotational direction. Furthermore, the driver 720 is connected to the drug dispensing member 323 by a rotation lock 750 that fixes the driver 720 to the drug dispensing member 323 in the rotational direction and allows relative axial movement between the driver 720 and the drug dispensing member 323.

[0411] The nut 38 is fixed to the actuator 316 in the rotational direction and movable in the axial direction. It is connected to the actuator 316 by a nut connector 705. The nut connector 705 is fixed to the actuator 316 in the rotational and axial directions. It protrudes from the actuator 316 in the proximal direction 1. In the illustrated exemplary embodiment, the nut connector 705 is formed substantially uniformly with the actuator 316. In other embodiments, the nut connector 705 may also be configured as a separate part fixed to the actuator 316 in the rotational and axial directions. The rotation lock 103 is formed between the nut connector 705 and the nut 38, as disclosed for a rotation lock 103 formed between the nut connector 18a and the nut 38 of the first mechanism 354.

[0412] In the dose setting state shown in Figures 80 and 81, the dose setting element 22 is rotatable relative to the housing 332. Furthermore, it is configured to remain stationary axially relative to the housing 332 during dose setting.

[0413] Similar to the first mechanism 354, the eighth mechanism 700 includes a clutch 113 that allows rotation of a nut 38 relative to a piston rod 44 during dose setting and locks the nut 38 to the piston rod 44 in the rotational direction during dose administration. Thus, the clutch 113 acts between the housing 332 and the dose setting element 22, similar to the clutch 113 of the first mechanism 354. Thus, the first engaging portion 114 of the clutch 113 is fixed axially and rotationally to the housing 332, and the second engaging portion 111 of the clutch 113 is fixed axially to the button 318 and rotationally to the dose setting element 22 (see, for example, Figures 80 and 81). Since the button 318 and the dose setting element 22 are fixed axially and rotationally to each other in the illustrated embodiment, the second engaging portion 111 is fixed axially and rotationally to both the button 318 and the dose setting element 22.

[0414] In the illustrated embodiment, the second engaging portion 111 is formed in the outer housing 730. In other embodiments, the second engaging portion 111 may also be formed as a separate part fixed to the outer housing 730 in the axial and rotational directions.

[0415] In the dose setting state, the button 318 is positioned distal to the housing 332, and in the dose administration state, the button 318 is positioned proximal to the housing 332. The movement of the button 318 from the distal position to the proximal position in the proximal direction 1 causes the eighth mechanism 700 to move from the dose setting state to the dose administration state.

[0416] The transition of the eighth mechanism 700 from the dose setting state to the dose administration state is achieved by closing the clutch 113. In the dose administration state shown in Figure 82, the first engaging portion 114 and the second engaging portion 111 of the clutch 113 engage with each other, thereby rotatably locking the dose setting element 22 and the button 318 to the housing 332. This also rotatably locks the nut 38 to the piston rod 44 via the nut connector 705, the actuator 316, and the housing 332.

[0417] Similar to the first mechanism 354, the eighth mechanism 700 includes a further clutch 107 that rotatably locks the dose setting element 22 to the driver 720 during dose setting and allows relative rotation between the driver 720 and the dose setting element 22 during dose administration. The further clutch 107 acts between the dispensing member 323 and the dose setting element 22. As can be seen from Figure 82, it has a further first engaging portion 110 rotatably fixed to the driver 720 and a further second engaging portion 108 rotatably fixed to the dose setting element 22.

[0418] The driver 720 is coupled to a further clutch 107 via a medication dispensing member 323. In the illustrated embodiment, a further first engaging portion 110 is fixed to the medication dispensing member 323 in the rotational and axial directions, and a further second engaging portion 108 is fixed to the dose setting element 22 in the rotational direction. Furthermore, a further second engaging portion 108 is fixed to the button 318 in the axial direction. Since the dose setting element 22 and the button 318 are fixed to each other in the rotational and axial directions, the further second engaging portion 108 is fixed to both the dose setting element 22 and the button 318 in the axial and rotational directions.

[0419] The transition of the eighth mechanism 700 from the dose setting state to the dose administration state is achieved by opening a further clutch 107. In the dose setting state, the further first engaging portion 110 engages with the further second engaging portion 108, and in the dose administration state, the further first engaging portion 110 is disengaged from the further second engaging portion 108.

[0420] In the illustrated embodiment, a further first engagement portion 110 is formed on the dispensing member 323, i.e., at the distal end of the dispensing member 323. In other embodiments, the further first engagement portion 110 may also be formed as a separate part fixed to the dispensing member 323 in the rotational and axial directions. A further second engagement portion 108 is exemplary formed on the actuation unit 316, i.e., on the button 318. In other embodiments, the further second engagement portion 108 may also be formed as a separate part fixed to the actuation unit 316, such as the button 318, in the axial and rotational directions.

[0421] In the illustrated embodiment, the second engaging portion 111 of the clutch 113 and the further second engaging portion 108 of the further clutch 107 are formed in the same portion of the eighth mechanism 700. This portion is located between the outer housing 730 and the dispensing member 323. This portion forms a portion 707 of the button 318. The portion 707 extends proximal 1 from the button 318. In other embodiments, the portion 707 may be configured as a separate element fixed to the button 318 in the rotational and axial directions.

[0422] As can be seen from Figure 80, the button 318 is biased distally by a biasing member 250 configured as a compression spring. The biasing member 250 acts between the medication dispenser 323 and the button 318.

[0423] To prevent the button 318 from detaching from the housing, the eighth mechanism 700 includes a retainer 797 that acts between the housing 332 and the button 318. The retainer includes a first retainer element 798 fixed axially to the button 318 and a second retainer element 799 fixed axially to the housing 332. When the first and second retainer elements 798, 799 are engaged, axial movement of the button 318 distally is restricted. In the dose setting state, the button 318 is biased distally by the biasing member 250 until further distal movement is restricted by the retainer 797. The retainer 797 allows axial movement of the button 318 proximal 1 against the biasing force of the biasing member 250, thereby transitioning the eighth mechanism 700 from the dose setting state to the dose administration state.

[0424] In the illustrated exemplary embodiment, the first retainer element 798 is formed at the button 318, that is, at portion 707 of the button 318, further comprising the additional second engagement portion 108 of the further clutch 107 and the second engagement portion 111 of the clutch 113. Thus, the first retainer element 798 is located at the proximal end of the button 318. The second retainer element 799 is formed in the housing 332, that is, in the outer housing 730.

[0425] Similar to the first mechanism 351, one of the first and second retainer elements 798, 799 may be configured as a flexible element that allows the other of the first and second retainer elements 798, 799 to pass through when the button 318 moves proximal during assembly of the button 318 into the housing 332. For example, the flexible element may be configured to bend radially when the first and second retainer elements 798, 799 pass through each other as the button 318 moves proximal during assembly.

[0426] The drug delivery member 323 is configured to remain axially stationary relative to the housing 332 during both dose setting and dose administration. The axial movement of the drug delivery member 323 is restricted by a blocker 752 acting between the drug delivery member 323 and the housing 332. The blocker 752 restricts the proximal movement of the drug delivery member 323 in the proximal direction 1. This includes a first locking portion 712 fixed axially to the drug delivery member 323 and a second locking portion 732 fixed axially to the housing 332. The first and second locking portions 712, 732 engage with each other to restrict the axial movement of the drug delivery member 323 in the proximal direction.

[0427] Axial movement of the dispensing member 323 distally is prevented by a biasing member 250 that biases the dispensing member 323 proximal to the button 318. Since the button 318 is prevented from moving distally by the retainer 797, the dispensing member 323 is pushed against the blocker 752 by the force of the biasing member 250.

[0428] Figures 83 to 85 show the actuation unit 316. The second engagement portion 111, a further second engagement portion 108, and the portion 707 that supports the first retainer element 798 are formed as a cylindrical portion of the actuation unit 316. The second engagement portion 111 is formed as radial teeth extending from the outer surface of portion 707. The second engagement portion 111 is located at the proximal end of portion 707. The teeth of the second engagement portion 111 are distributed around the entire circumference of portion 707. In other embodiments, the teeth may also cover only one or more sections around the circumference.

[0429] The first retainer element 798 is formed by the distally opposing surface of the second engagement portion 111, i.e., by the distally opposing surface of the teeth of the second engagement portion 111. In other embodiments, the first retainer element 798 may also be formed by a part of a button 318 separate from the second engagement portion 111.

[0430] As can be seen in Figure 85, the further second engaging portion 108 of the further clutch 107 is located on the inner surface of portion 707. The second engaging portion 108 is configured as radially extending teeth. Thereafter, the teeth extend radially inward from the inner surface of portion 707. The teeth cover the entire perimeter of portion 707. In other embodiments, the teeth may also cover one or more sections around portion 707.

[0431] In all mechanisms 354, 620, 630, 640, 650, 660, 700, and 800 according to the present invention, the spacing of the teeth of the engaging portions 108, 111, and 114 of the clutch 113 is equal to an integer multiple of the spacing of the teeth of the further engaging portions 108 and 110 of the further clutch 107, or vice versa. For example, both spacings may be equal. Furthermore, the teeth of the engaging portions 108, 111, and 114 of the clutch 113 are aligned with the teeth of the further engaging portions 108 and 110 of the further clutch 107, or vice versa.

[0432] The eighth mechanism 700 includes a dose-defining mechanism 115 that acts between the dose-setting element 22 and the housing 332. The counter element 116 of the dose-defining mechanism 115 is formed on the actuation unit 316, i.e., on the portion 707. Thereafter, the counter element 116 is positioned between the second engagement portion 111 at the proximal end of the portion 707 and the distal end face 80.

[0433] Similar to the first mechanism 354, the counter element 116 protrudes radially, i.e., radially outward. It is located in the elastically deformable section 120 of the portion 707. In exemplary embodiments, the deformable section 120 extends along the periphery of the portion 707. In other embodiments, the deformable section 120 may also be oriented parallel to the longitudinal axis, as in the case of the first mechanism 354.

[0434] Figures 86 to 88 show the outer housing 730 of the eighth mechanism 700. The outer housing 730 includes a dose stop unit 118 of the dose defining mechanism 115, which is fixed to the outer housing 730 in the axial and rotational directions. The dose stop unit 118 is located at the distal end of the housing 730. When the eighth mechanism 700 is in the dose setting state, the dose stop unit 118 is axially aligned with a counter element 116 provided on part 707 of the operating unit 316.

[0435] The dose stop units 118 are at equal distances from each other in the circumferential direction. This distance is equal to the minimum setting distance which corresponds to the minimum dose that can be set by the eighth mechanism 700. Since the counter element 116 is fixed in the rotational direction relative to the dose stop unit 118 during dose administration, the counter element 116 does not rotate back to the zero position which corresponds to a fixed rotational position where no dose is set. Therefore, individual dose stop units 118 also do not correspond to a fixed, unique dose setting.

[0436] In other embodiments, one of the counter element 116 and the dose stop unit 118 may be mounted on a component that rotates relative to a second component that carries the other of the counter element 116 and the dose stop unit 118 during dose administration. For example, one of the counter element 116 and the dose stop unit 118, e.g., the counter element 116, can be mounted on the dispensing member 323 or the driver 720 or a component rotatably fixed to the driver 720. The other of the counter element 116 and the dose stop unit 118, e.g., the dose stop unit 118, can then be rotatably fixed to the housing 332. One of the counter element 116 and the dose stop unit 118, e.g., the dose stop unit 118, can be mounted on a dose selector that is axially movable relative to the housing 332 and axially fixed to the button 318, for example, as in the case of the first mechanism 354. For example, the dose selector can further be rotatably fixed to the housing 332.

[0437] Although not shown, the eighth mechanism 700 may include a minimum dose stop mechanism and / or a maximum dose stop mechanism. The minimum dose stop mechanism may then act between the driver 720 and the housing 332, for example, between the driver 720 and the piston rod guide 342. For example, the proximal end of the driver 720 may engage with a stop feature of the housing 332 to stop the rotational movement of the driver 720 relative to the housing. The minimum dose stop mechanism may be configured as an axial stop or a radial stop.

[0438] The maximum dose stop mechanism can, for example, act between the driver 720 and the drug delivery member 323. The maximum dose stop can then restrict the relative axial movement of the driver 720 with respect to the drug delivery member 323. In these embodiments, distal movement of the drug delivery member 333 may be restricted relative to the housing 332 not only by the biasing member 250 but also by a hard stop. The maximum dose stop can be configured, for example, as an axial stop.

[0439] In an alternative embodiment, the maximum dose stop unit can be provided in the housing 332. For example, the driver 720 can engage with the maximum dose stop unit via the drug delivery element 740.

[0440] In an embodiment of the eighth mechanism 700 in which the rotation of the drug delivery member 323 is limited to less than one rotation around its longitudinal axis during dose setting, the maximum dose stop mechanism and / or minimum dose stop mechanism may be provided as a radial stop acting between the drug delivery element 323 and the housing 332. The radial stop can be provided, for example, between the portion 707 supporting the dose definition mechanism 115 and the housing 332. Alternatively, the radial stop may be provided directly between the drug delivery member 323 and the housing 332.

[0441] The second retainer element 799 is formed on the inner surface of the outer housing 730. It is configured as a radial projection extending along the periphery of the inner surface. The radial projection is oriented radially inward. Furthermore, it covers the entire circumference of the inner surface.

[0442] The first engaging portion 114 of the clutch 113 is formed as radial teeth. The first engaging portion 114 is located on the inner surface of the outer housing 730. It is located 1 proximal to the second retainer element 799 and spaced apart from the second retainer element 799. Proximal to the first engaging portion 114, the outer housing 730 includes the second locking portion 732 of the blocker 752. The second locking portion 732 is configured as a radial projection directed inward from the inner surface of the outer housing 730. It extends circumferentially and covers the entire circumference of the inner surface.

[0443] Figures 89 to 91 show the driver 720. The driver 720 includes a threaded portion 726 or proximal portion located inside the dispensing element 740. Both the dispensing element 740 and the threaded portion 726 are formed as hollow cylindrical portions. The threaded portion 726 carries the male threads of the drive thread 337 on its outer surface.

[0444] Furthermore, the driver 720 includes a coupling portion 725 attached to the distal end of the threaded portion 726. Between the coupling portion 725 and the threaded portion 726, the drug delivery element 740 is attached to the driver 720.

[0445] The coupling portion 725 has a first locking portion 722 of the rotation locking 750 formed thereon. The first locking portion 722 includes a longitudinal feature provided on the outer surface of the coupling portion 725. Furthermore, the first locking portion 722 includes two further longitudinal features 722. The longitudinal features are oriented parallel to the longitudinal axis of the eighth mechanism 700. They engage with corresponding longitudinal features 712 provided on the drug delivery member 323.

[0446] A drug delivery member 323 having a longitudinal feature 712 is shown in Figures 92 to 94. The rotation lock 750 is configured as a spline connection. Of the longitudinal features 712 and 722, exemplary, the longitudinal feature 722 of the driver 720 is configured as a radially extending protrusion, and of the longitudinal features 712 and 722, exemplary, the longitudinal feature 712 of the drug delivery member 323 is configured as a corresponding recessed section, such as a corresponding slit. In other embodiments, the longitudinal feature 712 may be configured as a protrusion, and the longitudinal feature 722 may be configured as a recessed section.

[0447] One of the longitudinal features 712, 722 is provided on the outer surface, and the other of the longitudinal features 712, 722 is provided on the inner surface. Exemplarily, the longitudinal feature 722 of the driver 720 is provided on the outer surface of the driver 720, and the longitudinal feature 712 of the drug dispensing member 323 is provided on the inner surface of the drug dispensing member 323. In other embodiments, the longitudinal feature 712 may be provided on the inner surface, and the longitudinal feature 722 may be provided on the outer surface.

[0448] The first locking portion 114 of the blocker 752 is provided on the drug delivery member 323. It is configured to engage with a second locking portion 732 provided on the outer housing 730. The first locking portion 114 extends radially from the outer surface of the drug delivery member 323, i.e., radially outward. The first locking portion 114 extends circumferentially and covers the entire circumference of the outer surface of the drug delivery member 323.

[0449] The medication dispensing member 323 includes a connector 716 at its distal end, configured to engage with the biasing member 250, i.e., the proximal end of the biasing member 250. The connector 716 is formed as a ring-shaped pocket at the distal end of the medication dispensing member 323. The distal end of the biasing member 250 abuts against the inner surface of the button 318 (see Figures 80 to 82).

[0450] In the eighth mechanism 700, the driver 720 is rotatably fixed to the dose setting element 22 via an additional clutch 107 during dose setting, so that the rotation of the dose setting element 22 during dose setting screws the driver 720 distally via the drive thread 337. This stores energy in the spring 40 coupled between the housing 332 and the driver 720. The coupler 710 forming the dispensing member 323 rotatably locks the driver 720 to the dose setting element 22 while allowing relative axial movement. As the driver 720 moves distally in the axial direction, the driver 720 moves into the dispensing member 323, as shown in Figure 81.

[0451] As can be seen in Figure 82, the axial movement of button 316 from the distal position to the proximal position causes clutch 113 to move from the open state to the closed state, and further causes clutch 107 to move from the closed state to the open state. During dose administration, button 318 and dose setting element 22 remain stationary axially relative to housing 332.

[0452] An alternative embodiment of the eighth mechanism 700 may also include an actuation unit 316 having a dose setting element 22 permanently fixed axially to the housing 332. The dose setting element 22 can then be coupled to the housing 332 via an axial lock that prevents relative axial movement of the dose setting element 22 and the housing 332 and allows relative rotational movement. The axial lock can be configured as disclosed for the axial lock 535 of the sixth mechanism 650 shown in Figure 70. The button 318 can then be connected to the dose setting element 22 by a rotation lock that prevents relative rotation and allows relative axial movement of the button 318 and the dose setting element 22. The rotation lock can be configured as disclosed for the rotation lock 510 of the sixth mechanism 650. The part 707 and nut connector 705 can then be fixed to the button 318 in the axial and rotational directions.

[0453] In alternative embodiments of the first to sixth mechanisms 354, 610, 620, 630, 640, and 650, the drug delivery element 334 may also be fixed axially and rotationally to the driver 336, as disclosed for the eighth mechanism 700. This allows the drug delivery element 334 to move axially during dose setting and dose adjustment. Thus, the markers 166 on the outer surface of the drug delivery element 334 can be offset axially from one another. This allows for larger markers compared to an arrangement where all markers are located in the same axial position on the outer surface of the drug delivery element 334. For example, the markers may be arranged along a helical path.

[0454] In these embodiments, the drug delivery member 323 can be configured as a coupler that remains stationary in the axial direction during dose setting and / or dose delivery. The driver 336 and drug delivery element 334 can then be connected to the coupler via a rotation lock that prevents relative rotation and allows relative axial movement.

[0455] In these alternative embodiments, the coupler may remain axially stationary relative to the housing 332 during the transition of mechanisms 354, 610, 620, 630, 640, and 650 from the dose setting state to the dose administration state. In other alternative embodiments, the coupler may be axially movable relative to the housing 332 during the transition of the mechanism from the dose setting state to the dose administration state. For example, the coupler may be axially fixed to the button 318.

[0456] In all embodiments of the mechanisms 354, 610, 620, 630, 640, 650, 660, and 700 according to this disclosure, the drug delivery elements 334, 681, and 740 may be coupled to the housing 332 by additional screw connections provided in addition to the drive threads 337. The additional screw connections may have different pitches, such as a larger or smaller pitch than the drive threads 337. This will be described below in relation to the ninth mechanism 800 according to the present invention.

[0457] Figure 95 shows a cross-sectional view of the ninth mechanism 800 in a dose-setting state with no dose set, in a cross-section parallel to the longitudinal axis. Unless otherwise disclosed, the ninth mechanism 800 is configured as disclosed for the eighth mechanism 700, and vice versa.

[0458] The ninth mechanism 800 includes a drug delivery element 830 and a driver 820, which are configured as two separate parts. Figures 96 to 98 show the driver 820, and Figures 99 to 100 show the drug delivery element 840.

[0459] An additional threaded connection 802 is provided between the outer housing 810 of the ninth mechanism 800 and the drug delivery element 830. The drug delivery element 830 is configured as a cylindrical member, which carries the male threads of the additional threaded connection 802 on its outer surface. The outer housing 810 includes female threads for the additional threaded connection 802 on its inner surface, thereby engaging the female threads of the outer housing 810 with the male threads of the drug delivery element 830.

[0460] The driver 820 and the dispensing element 840 are coupled to each other by a rotation lock 804 that allows relative axial movement and prevents relative rotation. Thus, the driver 820 includes a longitudinal feature 822, and the dispensing element 830 includes a corresponding longitudinal feature 832 of the rotation lock 804, thereby the longitudinal features 822, 832 engage with each other. Exemplarily, the longitudinal feature 822 of the driver 820 is configured as a longitudinal radial projection, and the longitudinal feature 832 of the dispensing element 830 is configured as a longitudinal recess section. The driver 820 includes a further longitudinal feature 822 of the rotation lock 804 that engages with a corresponding further longitudinal feature 832 of the dispensing element 830. The rotation lock 802 is configured similarly to the connector 339 of the first mechanism 354.

[0461] When the dose setting element 22 rotates during dose setting, the dispensing element 830 is driven by the driver 820 to move axially along the additional screw connection 802. The pitch of the additional screw connection 802 may be greater or less than the pitch of the drive thread 337.

[0462] All other mechanisms 354, 610, 620, 630, 640, 650, and 660 according to the present invention may also have a dispensing element 830 such that it is coupled to the housing 332 via an additional screw connection 802 and to the driver 820 via a rotary lock 804.

[0463] Next, the drug delivery element 830 may be coupled to the dose setting element 22 via the driver 820. In alternative embodiments of mechanisms 354, 610, 620, 630, 640, 650, 660, 700, and 800, the dose setting element 22 may be coupled to the driver 820 via the drug delivery element 830. [Explanation of Symbols]

[0464] 1. Proximal direction 3 dose distance 12 Distal end 14 Proximal end 18a Cylindrical section 20 Intermediate members 21 Gripping surface 22 Dosage Setting Elements 24 Carriers 26 connectors 38 nuts 39 Opening 40 springs 44 Piston Rod 46 bearings 76 Ribs 80 End face 81 Axial locking 82 Axial fixing means 84 Ribs 86 Axial fixing means 88 Undercut 90 Rotation fixing means 92 Rotation fixing means 93 Toothed part 94 Rotation fixing means 96 Rotation fixing means 97 Retainer 98a First retainer element 98b Further first retainer element 102 Second retainer element 103 Rotation lock 104 Rib 106 Groove 107 Further clutch 108 Second engaging portion, further second engaging portion 110 Further first engagement portion 111 Second engaging portion 112 Joined Sections 113 Clutch 114 First engaging part 115 Dose Definition Mechanism 116 counter elements 117 Chamfered section 118 Dose stop part 119 Further dose termination section 120 Elastically deformable sections 121 Notch 122 First Aspect 123 Second Aspect 124 Blocking part 126 Zero-dose stop unit 128 Maximum dose stop part 130 opening 132 slots 134 Ribs 136 Protrusion 136a Chamfered surface 138 Ribs 140 Groove 142 Axial fixing means 144 Intake 146 Axial fixing means 148 Rotation fixing means 150 rotation lock 152 Rotation lock 156 Ribs 158 Opening 166 windows 168 labels 172 Female thread 186 Opening 189 Screw connection 190 Male screw thread 191 Flattening Section 192 Female thread 193 Axial stop 194 Axial stop 196 Front 198 Proximal connector 199 Stop part 200 Bearing Connectors 250 biasing member 300 Pharmaceutical administration devices 301 Cap 302 Longitudinal axis 305 Container holder 306 Needle Connector 307 Connector 316 Actuator Unit 318 buttons 323 Drug administration component 332 Housing 333 Outer Housing 334 Medication elements 336 drivers 337 drive screw threads 338 Opening 339 Connector 340 Spring Connector 342 Piston rod guide 348 Pharmaceutical containers 349 Needle end 350 pistons 354 The first mechanism 360 Dose Selector 361 Inner self 362 Recessed Section 364 Chamfered section 366 Fracture surface 367 Groove 368 Feedback Elements 371 Inner self 373 Stop part 374 Stop part 375 Connector 382 Housing Connector 384 Container Connector 386 Spring Connector 387 Outer body 388 Inner body 390 Fracture 391 Part 1 392 Engagement Section 395 Part 2 400 Blocking mechanism 401 First element 403 Second element 410 Feedback mechanism 421 Exterior 422 Inner self 424 connector 430 Broccoli 440 Maximum Dose Mechanism 450 Zero-dose mechanism 461 First end 462 Second end 510 Rotation lock 520 Rotation lock 530 Axial locking 535 Axial locking 540 Dose Selector 550 Dose Selector 552 Axial locking 554 Rotation lock 561 First engaging portion 562 Second engaging portion 565 Further first engagement portion 566 Further second engagement portion 610 Second mechanism 620 Third mechanism 621 First retainer element 622 Second retainer element 630 The fourth mechanism 640 The fifth mechanism 650 The sixth mechanism 651 Second engaging portion, further second engaging portion 653 Protrusion 654 Protrusion 660 The seventh mechanism 662 Rotation lock 670 Driver 671 Distal portion 672 Longitudinal features 674 Proximal portion 680 Medication Dispensing Components 681 Medication elements 682 Stopping surface 683 Longitudinal features 685 Carriers 690 Outer Housing 694 Proximal stopping part 700 The 8th mechanism 705 Nut Connector 707 parts 710 Coupler 712 First locking portion 714 First locking part 716 connector 720 Driver 722 First locking portion 725 Joining part 726 Screw part 730 Outer Housing 732 Second locking portion 740 medication elements 745 Joint 750 rotation lock 752 Broccola 797 Retainer 798 First retainer element 799 Second retainer element 800 The 9th mechanism 802 Additional screw connections 804 Rotation lock 810 Outer body 820 Driver 822 Longitudinal features 830 Medication elements 832 Longitudinal features

[0465] This disclosure also covers the embodiments listed below. 1. Mechanisms (354, 610, 620, 630, 640, 650, 660, 700, 800) for an automated drug dispensing device (300), Housing (332) and, Dose setting element (22), Button (318), A piston rod (44) is fixed to the housing (332) in the rotational direction and movable in the axial direction, Nut (38) and, Spring (40) and, Equipped with, The dose setting element (22) is configured to be grasped by the user of the device in order to set the dose to be administered by rotating the dose setting element (22) relative to the housing (332) when the mechanism (354, 610, 620, 630, 640, 650, 660, 700, 800) is in the dose setting state. The rotation of the dose setting element (22) stores energy in the spring (40), The rotation of the dose setting element (22) moves the nut (38) proximal to the piston rod (44) by a dose distance (3), and the dose distance (3) is proportional to the dose. The mechanism (354, 610, 620, 630, 640, 650, 660, 700, 800) is configured such that when the button (318) is moved relative to the housing (332), it switches from the dose setting state to the dose administration state. The spring (40) is coupled to the nut (38) in the dose-administering state, and by releasing the energy accumulated during dose setting, causes the nut (38) to move automatically in the proximal direction (1). The piston rod (44) is configured to move proximal (1) by a dose distance (3) together with the nut (38) when the mechanism (354, 610, 620, 630, 640, 650, 660, 700, 800) is in a dose-administering state, thereby administering the dose. mechanism.

[0466] 2. The dose setting element (22) and the button (318) are movable relative to each other. Mechanism of Embodiment 1 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0467] 3. The button (318) is axially movable relative to the dose setting element (22), and the button (318) is fixed in the rotational direction relative to the dose setting element (22). At least one mechanism of a prior embodiment (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0468] 4. The dose setting element (22) and the button (318) are fixed to each other during dose setting and dose administration. Mechanism of Embodiment 1 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0469] 5. The dose setting element (22) is fixed in a rotational direction relative to the housing (332) when a dose is being administered. At least one mechanism of a prior embodiment (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0470] 6. The dose setting element (22) is configured to remain stationary axially relative to the housing (332) when the piston rod (44) moves proximal (1) to administer the dose. At least one mechanism of a prior embodiment (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0471] 7. The dose setting element (22) is fixed axially to the housing (332) during dose setting and dose administration. At least the mechanism of Embodiment 6 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0472] 8. The button (318) is configured to remain stationary axially relative to the housing (332) when the piston rod (44) moves proximal (1) to administer a dose. At least one mechanism of a prior embodiment (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0473] 9. Further comprising drug delivery components (323, 670), The drug dispensing members (323, 670) are configured to rotate relative to the housing (332) during dose setting and during dose administration. The drug delivery members (323, 670) are configured to remain stationary in the axial direction relative to the housing (332) during dose administration. At least one mechanism of a prior embodiment (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0474] 10. The drug delivery member (323, 670) includes a first part (24) and a second part (334), The first part (24) is movable axially relative to the second part (334) and fixed in the rotational direction. Mechanism of Embodiment 9 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0475] 11. The first part (24) is fixed axially to the button (318), and / or the second part (334) is fixed axially to the housing (332). At least one mechanism of Embodiments 9 and 10 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0476] 12. The rotational position of the drug dispensing member (323, 670) defines the dose, and for example, the drug dispensing member (323, 670), such as the first part (24), includes one of the dose stopping parts (118, 119) and counter elements (116) of the dose defining mechanism (115). At least one mechanism from embodiments 9 to 11 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0477] 13. The drug dispensing members (323, 670) are configured to remain axially stationary relative to the housing (332) while energy is being stored in the spring (40) during dose setting. At least one mechanism from Embodiments 9 to 12 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0478] 14. The drug dispensing member (323, 670) is coupled between the spring (40) and the dose setting element (22) during dose setting, and transmits energy from the dose setting element (22) to the spring (40). At least one mechanism from Embodiments 9 to 13 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0479] 15. The medication dispensing component (323, 670) includes a label (168) that visually indicates the setting of the dosage. For example, the label (168) is provided on the second part (334), At least one mechanism from embodiments 9 to 14 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0480] 16. The dose setting element (22) is configured to remain stationary in the axial direction relative to the drug delivery member (323, 670) during dose administration. At least one mechanism from embodiments 9 to 15 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0481] 17. The dose setting element (22) is configured to remain stationary in the axial direction relative to the drug dispensing member (323, 670) during dose setting. At least one mechanism from embodiments 9 to 16 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0482] 18. Further containing Broccola (430), The blocker (430) acts between the button (318) and the housing (332), The blocker (430) prevents the button (318) from moving axially distally (1) relative to the housing (332). At least one mechanism of a prior embodiment (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0483] 19. The blockers (430, 752) act between the drug delivery members (323, 670) and the housing (332). For example, a blocker (430, 752) is provided on one of the housing (332) and the drug dispensing member (323, 670) and engages with the other of the housing (332) and the drug dispensing member (323, 670). At least one mechanism from Embodiment 18 and Embodiments 9-17 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0484] 20. The blockers (430, 752) are configured as axial stop units. At least the mechanisms of embodiments 18 and 19 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0485] 21. The blocker (430) is configured as a one-way blocker. The blocker (430) allows relative axial movement between the housing (332) and the counter members (323, 670, 334) in a first direction, and prevents relative axial movement between the housing (332) and the counter members (323, 670, 334) in a second direction opposite to the first direction. At least the mechanisms of embodiments 18 to 20 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0486] 22. The blocker (430) is configured as a flexible element that snaps into a blocking position when the counter members (323, 670, 334) are assembled to the housing (332). Mechanism of Embodiment 21 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0487] 23. The counter members (323, 670, 334) are part of the medication dispensing members (323, 670). At least one of embodiments 21 and 22, and at least the mechanism of embodiment 19 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0488] 24. Blocker (752) is configured as a rigid element. At least one mechanism from embodiments 21 to 23 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0489] 25. Blocker (752) is composed of circumferential projections such as annular projections. At least one mechanism from embodiments 21 to 24 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0490] 26. The mechanism (354, 610, 620, 630, 640, 650, 660, 700, 800) includes stoppers (373, 374) for restricting the proximal movement of the button (318) during dose administration. At least one mechanism of a prior embodiment (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0491] 27. The drug dispensing members (323, 670) are coupled between the stopper (374) and the housing (332). At least one mechanism from Embodiment 26 and Embodiments 9 to 17 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0492] 28. The stopping part (373) is provided to the housing (332), such as the inner surface (371) of the housing (332). Mechanism of Embodiment 26 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0493] 29. The stopper (373) acts between the housing (332) and the housing connector (360) which is fixed axially to the button (318). At least one mechanism from embodiments 26 to 28 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0494] 30. The stopper (373) acts directly between the housing (332) and the button (318). At least one mechanism from embodiments 26 to 28 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0495] 31. The stop unit (373) is provided on the dose setting element (22), Mechanism of Embodiment 26 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0496] 32. The stopping parts (373, 374) are configured as axial stopping parts. At least one mechanism from embodiments 26 to 31 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0497] 33. Further includes retainers (97, 797) to prevent the button (318) and / or dose setting element (22) from coming off the housing (332), The retainer (97, 797) includes a first retainer element (98a, 621, 798) and a second retainer element (102, 622, 799), The first retainer elements (98a, 621, 798) and the second retainer elements (102, 622, 799) are configured to engage with each other to prevent the button (318) and / or the dose setting element (22) from coming off the housing (332). At least one mechanism of a prior embodiment (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0498] 34. The retainer (97) acts between the medication dispensing member (323, 670) on one side and the button (318) and / or dose setting element (22) on the other side. At least one mechanism from Embodiment 33 and Embodiments 9 to 17 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0499] 35. The retainer (797) acts directly between the housing (332) and the button (318). At least the mechanism of Embodiment 33 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0500] 36. The dose setting element (22) is fixed axially to the housing (332), The retainer (97) is configured to prevent the button (318) from coming off the housing (332), The retainer (97) acts between the dose setting element (22) and the button (318). At least the mechanism of Embodiment 33 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0501] 37. The first retainer elements (98a, 621, 798) and the second retainer elements (102, 622, 799) are configured to move away from each other, allowing axial movement of the button (318) and / or the dose setting element (22) in the proximal direction (1) relative to the housing (332). At least one mechanism from embodiments 33 to 36 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0502] 38. The retainers (97, 797) are configured as axial stoppers. At least one mechanism from embodiments 33 to 37 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0503] 39. Further equipped with drivers (336, 660, 720, 820), The drivers (336, 660, 720, 820) are coupled between the spring (40) and the nut (38) when the mechanism (354, 610, 620, 630, 640, 650, 660, 700, 800) is in a dose-administered state, and transmit the energy stored in the spring (40) to the nut (38). The drivers (336, 660, 720, 820) are configured to move distally when the mechanism (354, 610, 620, 630, 640, 650, 660, 700, 800) is in the dose setting state, and to move proximal (1) when the mechanism (354, 610, 620, 630, 640, 650, 660, 700, 800) is in the dose administration state. At least one mechanism of a prior embodiment (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0504] 40. The spring (40) is coupled between the driver (336, 660, 720, 820) and the housing (332). Mechanism of Embodiment 39 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0505] 41. The drivers (336, 660, 720, 820) are rotationally driven by a spring (40) during dose administration. At least one mechanism of embodiments 39 and 40 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0506] 42. The drivers (336, 660, 720, 820) are coupled between the spring (40) and the dose setting element (22) during dose setting to transfer energy from the dose setting element (22) to the spring (40). At least one mechanism from embodiments 39 to 41 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0507] 43. The drivers (336, 660, 720, 820) are fixed to the nut (38) in the rotational direction when the mechanism (354, 610, 620, 630, 640, 650, 660, 700, 800) is in the dose setting state, and are movable to the nut (38) in the rotational direction when the mechanism (354, 610, 620, 630, 640, 650, 660, 700, 800) is in the dose administration state. At least one mechanism from embodiments 39 to 42 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0508] 44. The drivers (336, 660, 720, 820) are fixed in the rotational direction relative to the dose setting element (22) when the mechanism (354, 610, 620, 630, 640, 650, 660, 700, 800) is in the dose setting state, and are movable in the rotational direction relative to the dose setting element (22) when the mechanism (354, 610, 620, 630, 640, 650, 660, 700, 800) is in the dose administration state. At least one mechanism from embodiments 39 to 43 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0509] 45. The drivers (336, 660, 720, 820) are rotatably movable relative to the housing (332) during dose setting and dose administration. At least one mechanism from embodiments 39 to 44 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0510] 46. ​​The mechanism (354, 610, 620, 630, 640, 650, 660, 700, 800) is equipped with a drive screw thread (337) that connects the driver (336, 660, 720, 820) to the housing (332), The drive thread (337) converts the torque provided by the spring (40) into axial movement of the driver (336, 660, 720, 820). At least one mechanism from embodiments 39 to 45 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0511] 47. The drivers (336, 660, 720, 820) screw-engage with the housing (332) via the drive thread (337). Mechanism of Embodiment 46 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0512] 48. The drivers (336, 660, 720, 820) are connected between the nut (38) and the drug delivery member (323, 670). For example, the drivers (336, 660, 720, 820) engage with the drug dispensing members (323, 670). At least one mechanism from embodiments 39 to 47 and at least one mechanism from embodiments 9 to 17 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0513] 49. The drivers (336, 660, 720, 820) are fixed to the drug dispensing members (323, 670) in the rotational direction and / or movable in the axial direction. At least one mechanism from embodiments 39 to 48 and at least one mechanism from embodiments 9 to 17 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0514] 50. The drivers (336, 660, 720, 820) are rotatably fixed to the medication elements (334, 671, 740, 830) that indicate the set dose to the user, for example, by a marker (168) visible through a window (166) in the housing (332). At least one mechanism from embodiments 39 to 49 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0515] 51. The drivers (336, 660, 720, 820) are axially fixed to the medication elements (334, 671, 740, 830). At least the mechanism of Embodiment 50 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0516] 52. The drivers (336, 660, 720, 820) are axially movable relative to the medication elements (334, 671, 740, 830). For example, the medication elements (334, 671, 740, 830) are screw-connected to the housing (323). At least the mechanism of Embodiment 50 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0517] 53. The medication elements (334, 671, 740) are coupled between the dose setting element (22) and the driver (336, 660, 720) to transmit force from the dose setting element (22) to the driver (336, 660, 720). At least one mechanism of embodiments 50 and 52 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0518] 54. The medication element (830) is driven by the driver (820) during dose setting. At least one mechanism of embodiments 50 and 52 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0519] 55. Further including dose-defining mechanism (115), The dose-defining mechanism (115) acts between the dose-setting element (22) and the housing (332) during dose setting. The dose-defining mechanism (115) has at least one dose-stopping unit (118, 119) and a counter element (116), The counter element (116) is configured to rotate relative to the dose stop unit (118, 119) when the dose setting element (22) rotates during dose setting. The counter element (116) is configured to engage with the dose stop unit (118, 119) when the dose is set. At least one mechanism of a prior embodiment (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0520] 56. The engagement of the counter element (116) with the dose stop section (118, 119) prevents the spring (40) from releasing the energy accumulated when the dose setting element (22) rotates. Mechanism of Embodiment 55 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0521] 57. The counter element (116) is configured to disengage from the dose stop unit (118, 119) when the mechanism (354, 610, 620, 630, 640, 650, 660, 700, 800) transitions from the dose setting state to the dose administration state. At least one mechanism of embodiments 55 and 56 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0522] 58. The counter element (116) is configured to disengage from the dose stop units (118, 119) by moving axially relative to the dose stop units (118, 119). At least the mechanism of Embodiment 57 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0523] 59. One of the dose stop units (118, 119) and the counter element (116) is configured to rotate relative to the other of the dose stop units (118, 119) and the counter element (116), and / or relative to the housing (332) during dose administration. At least one mechanism of embodiments 55 to 58 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0524] 60. One of the dose stop units (118, 119) and the counter element (116) is fixed to the housing (332) in the rotational direction. At least one mechanism from embodiments 55 to 58 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0525] 61. One of the dose stop units (118, 119) and the counter element (116) is movable axially relative to the dose setting element (22). At least the mechanism of Embodiment 59 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0526] 62. One of the dose stop units (118, 119) and the counter element (116) is fixed axially to the button (318). At least one mechanism of Embodiments 59 and 61 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0527] 63. One of the dose stop units (118, 119) and the counter element (116) is fixed axially to the housing (332). At least one mechanism of embodiments 59 and 61 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0528] 64. One of the dose-stopping units (118, 119) and the counter element (116) is fixed to the outer housing portion (360, 540) of the mechanism (354, 610, 620, 630, 640, 650, 660, 700, 800). At least one mechanism from embodiments 59 to 63 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0529] 65. The other of the dose-stopping unit (118, 119) and the counter element (116) is fixed to the drug dispensing member (323, 670) in the rotational direction. At least one mechanism from embodiments 59 to 64 and at least one mechanism from embodiments 9 to 17 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0530] 66. The other of the dose stop unit (118, 119) and the counter element (116) is fixed axially to the housing (332). At least the mechanisms of embodiments 59 to 65 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0531] 67. The other of the dose stop unit (118, 119) and the counter element (116) is axially movable relative to the button (318). At least the mechanism of Embodiment 66 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0532] 68. The other of the dose stop section (118, 119) and the counter element (116) is axially movable relative to the housing (332). At least the mechanism of Embodiment 65 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0533] 69. The other of the dose stop unit (118, 119) and the counter element (116) is fixed axially to the button (318). At least the mechanism of Embodiment 68 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0534] 70. Mechanisms (354, 610, 620, 630, 640, 650, 660, 700, 800) include a blocking mechanism (400) having a first element (156) and a second element (116), The first element (156) engages with the second element (116) when the button (318) is released during dose administration, preventing the mechanism (354, 610, 620, 630, 640, 650, 660, 700, 800) from transitioning from the dose administration state to the dose setting state. At least one mechanism from the preceding embodiments (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0535] 71. The first element (156) rotates in a first direction relative to the second element (116) during dose setting, and rotates in a second direction opposite to the first direction during dose administration. At least the mechanism of Embodiment 70 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0536] 72. The first element (156) is configured as a circumferential rib extending longitudinally around the axis of the housing (332), The second element (116) is configured as a stopper that moves along the circumferential rib during dose administration. At least one mechanism of embodiments 70 and 71 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0537] 73. The second element (116) passes through the first element (156) when the button (318) is released at the end of dose administration. At least one mechanism from embodiments 70 to 72 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0538] 74. The second element (116) passes through the first element (156) during the transition from the dose setting state to the dose administration state mechanism (354, 610, 620, 630, 640, 650, 660, 700, 800). At least one mechanism from embodiments 70 to 73 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0539] 75. The second element (116) passes through the opening (158) in the first element (156) during the transition from the dose setting state to the dose administration state mechanism (354, 610, 620, 630, 640, 650, 660, 700, 800). Mechanism of Embodiment 74 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0540] 76. The first element (156) includes a recessed section (362) in the opening (158), When the button (318) is released after passing through the opening (158) while transitioning the mechanism (354, 610, 620, 630, 640, 650, 660, 700, 800) from the dose setting state to the dose administration state, the second element (116) engages with the recessed section (362), The engagement of the second element (116) with the recessed section (362) prevents the mechanism (354, 610, 620, 630, 640, 650, 660, 700, 800) from transitioning back to the dose setting state. Mechanism of Embodiment 75 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0541] 77. The first element (156) of the blocking mechanism (400), and one of the dose stop units (118, 119) and the counter element (116), for example, the dose stop units (118, 119), are fixed to the same members (360, 540, 550) of the mechanism (354, 610, 620, 630, 640, 650, 660, 700, 800), The second element (116) of the blocking mechanism (400), and the other of the dose stop units (118, 119) and the counter element (116), for example the counter element (116), are fixed to the same further member (24) of the mechanism (354, 610, 620, 630, 640, 650, 660, 700, 800). At least one mechanism from embodiments 70 to 76 and at least one mechanism from embodiments 55 to 69 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0542] 78. One of the first element (156) and the second element (116) of the blocking mechanism (400), and one of the dose stop units (118, 119) and the counter element (116) are formed by a single element. For example, the second element (116) of the blocking mechanism (400) and the counter element (116) of the dose-defining mechanism (115) are formed by a single element. At least the mechanism of Embodiment 77 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0543] 79. The mechanism (354, 610, 620, 630, 640, 650, 660, 700, 800) includes a maximum dose mechanism (440) that suppresses further rotation of the dose setting element (22) when the dial setting exceeds the maximum dose setting, and the maximum dose mechanism (440) includes a maximum dose stop unit (128) and a blocking unit (124), The blocking unit (124) is configured to engage with the maximum dose stop unit (128) when the dial setting exceeds the maximum dose setting. At least one mechanism of the embodiment (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0544] 80. The maximum dose stop unit (128) and the block unit (124) are configured to rotate relative to each other during dose setting. At least the mechanism of Embodiment 79 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0545] 81. The maximum dose stop unit (128) is configured as a radial stop unit, and the blocking unit (124) is configured to rotate relative to the maximum dose stop unit (128) when the dial setting exceeds the maximum dose. At least the mechanism of Embodiment 80 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0546] 82. One of the maximum dose stop unit (128) and the blocking unit (124) is fixed to the housing (332) in the rotational direction. At least one mechanism from embodiments 79 to 81 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0547] 83. One of the maximum dose stop unit (128) and the blocking unit (124) is fixed to the outer housing portion (333, 360, 540) of the mechanism (354, 610, 620, 630, 640, 650, 660, 700, 800). At least the mechanism of Embodiment 82 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0548] 84. The other of the maximum dose stop unit (128) and the blocking unit (124) is fixed in the rotational direction to the drug dispensing member (323, 670). At least one of embodiments 82 and 83, and at least one mechanism from embodiments 9 to 17 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0549] 85. The other of the maximum dose stop unit (128) and the blocking unit (124) is fixed to a coupling member (24) that rotates the drug dispensing member (323, 670) to the dose setting element (22) during dose setting. At least one mechanism of Embodiment 84 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0550] 86. One of the dose-stopping parts (118, 119) and the counter element (116), such as the dose-stopping parts (118, 119), and one of the maximum dose-stopping parts (128) and the blocking part (124), such as the maximum dose-stopping part (128), are fixed to the same member (333, 360, 540, 550) of the mechanism (354, 610, 620, 630, 640, 650, 660, 700, 800), and / or The other of the counter elements (116), such as the dose stop section (118, 119) and the counter element (116), and the other of the blocking section (124), such as the maximum dose stop section (128) and the blocking section (124), are fixed to the same further member (24) of the mechanism (354, 610, 620, 630, 640, 650, 660, 700, 800). At least one mechanism from embodiments 79 to 85 and at least one mechanism from embodiments 55 to 69 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0551] 87. The mechanism (354, 610, 620, 630, 640, 650, 660, 700, 800) includes a zero-dose mechanism (450) that prevents further axial movement of the nut (38) at the end of dose administration. The zero-dose mechanism (450) includes a zero-dose stop unit (126) and a further block unit (124), A further blocking unit (124) is configured to engage with a zero-dose stop unit (126) at the end of dose administration. At least one mechanism of a prior embodiment (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0552] 88. The zero-dose stop section (126) and the further block section (124) are configured to rotate relative to each other during dose administration. At least the mechanism of Embodiment 87 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0553] 89. The zero-dose stop unit (126) is configured as a radial stop unit, and the further blocking unit (124) is configured to rotate relative to the zero-dose stop unit (126) at the end of dose administration. At least the mechanism of Embodiment 88 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0554] 90. One of the zero-dose stop unit (126) and the further block unit (124) is fixed to the housing (332) in the rotational direction. At least one mechanism from embodiments 87 to 89 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0555] 91. One of the zero-dose stop unit (126) and the further blocking unit (124) is fixed to the outer housing portion (360, 540) of the mechanism (354, 610, 620, 630, 640, 650, 660, 700, 800). At least the mechanism of Embodiment 90 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0556] 92. The other of the zero-dose stop unit (126) and the further blocking unit (124) is fixed in the rotational direction to the drug delivery member (323, 670). At least one of embodiments 90 and 91, and at least one mechanism from embodiments 9 to 17 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0557] 93. The other of the zero dose stop unit (126) and the further blocking unit (124) is fixed to a coupling member (24) that rotates the drug dispensing member (323, 670) to the dose setting member during dose setting. At least one mechanism of Embodiment 92 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0558] 94. One of the dose-stopping units (118, 119) and the counter element (116), such as the dose-stopping unit (118, 119), and one of the zero-dose-stopping unit (126) and the further blocking unit (124), such as the zero-dose-stopping unit (126), are fixed to the same member (360, 540, 550) of the mechanism (354, 610, 620, 630, 640, 650, 660, 700, 800), and / or The other of the counter elements (116), such as the dose stop section (118, 119) and the counter element (116), and the other of the blocking section (124), such as the zero dose stop section (126) and the blocking section (124), are fixed to the same further members of the mechanism (354, 610, 620, 630, 640, 650, 660, 700, 800). At least one mechanism from embodiments 87 to 93 and at least one mechanism from embodiments 55 to 69 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0559] 95. The maximum dose stop section (128) and the zero dose stop section (126), one of the blocking sections (124) of the maximum dose stop section (128) and the maximum dose mechanism (440), and the zero dose stop section (126) and the further blocking section (124) of the zero dose stop section (126) are fixed to the same member (360, 540, 550) of the mechanism (354, 610, 620, 630, 640, 650, 660, 700, 800), The other of the maximum dose stop section (128) and the stop section (124) of the maximum dose mechanism (440), such as the blocking section (124) and the further blocking section (124), and the other of the zero dose stop section (126) and the further blocking section (124) of the zero dose mechanism (450), are fixed to the same further member (24) of the mechanism (354, 610, 620, 630, 640, 650, 660, 700, 800). At least one mechanism from embodiments 87 to 94 and at least one mechanism from embodiments 79 to 86 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0560] 96. The blocking portion (124) of the maximum dose mechanism (440) forms a further blocking portion (124) of the minimum dose mechanism (450). At least one mechanism from embodiments 87 to 95 and at least one mechanism from embodiments 79 to 86 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0561] 97. The mechanism (354, 610, 620, 630, 640, 650, 660, 700, 800) includes a break (390) to stop the movement of the nut (38) when the button (318) is released during dose administration. At least one mechanism of a prior embodiment (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0562] 98. The fracture (390) includes a first fracture portion (156) and a second fracture portion (124) that engages with the first fracture portion (156) when the button (318) is released during dose administration. At least the mechanism of Embodiment 97 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0563] 99. The first fracture portion (156) rotates in a first direction relative to the second fracture portion (124) during dose setting, and rotates in a second direction opposite to the first direction during dose administration. At least the mechanism of Embodiment 98 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0564] 100. The first fracture section (156) is configured as a circumferential rib extending longitudinally around the axis of the housing (332), The second fracture section (124) is configured as a stop section that moves along the circumferential rib during dose administration. At least the mechanisms of embodiments 98 and 99 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0565] 101. The second rupture portion (124) engages with the first rupture portion (156) by friction when the button (318) is released during dose administration. At least the mechanisms of embodiments 98 to 100 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0566] 102. The first fracture section (156) includes a plurality of grooves (367), The second break portion (124) is configured to engage with at least one of the grooves (367) when the button (318) is released during dose administration. At least the mechanisms of embodiments 98 to 101 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0567] 103. The first element (156) of the blocking mechanism (400) forms the first fracture portion (156) of the fracture portion (390), and / or The second element (116) of the blocking mechanism (400) forms the second fracture portion (124) of the fracture portion (390). At least one mechanism from embodiments 70 to 78 and at least one mechanism from embodiments 98 to 102 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0568] 104. Clutch (113) further included, The clutch (113) rotates the nut (38) onto the piston rod (44) during dose administration and rotates the nut (38) away from the piston rod (44) during dose setting. At least one mechanism of a prior embodiment (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0569] 105. The clutch (113) rotates the nut (38) to the piston rod (44) via the housing (332) and, for example, via the dose setting element (22) and / or button (318) during dose administration. At least the mechanism of Embodiment 104 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0570] 106. The clutch (113) acts between the button (318) and the housing (332). At least one mechanism of embodiments 104 and 105 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0571] 107. The clutch (113) has a first engaging portion (114, 561) fixed to the housing (332) in the rotational direction, and a second engaging portion (108, 562, 651) fixed to the button (318) in the rotational direction. The first engaging portion (114, 561) is configured to move and engage with the second engaging portion (108, 562, 651), thereby locking the nut (38) to the piston rod (44) in the rotational direction. At least one mechanism of embodiments 104 to 106 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0572] 108. The first engaging portion (114, 561) is fixed axially to the housing (332). At least one mechanism from embodiments 104 to 107 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0573] 109. Including further clutches (107), A further clutch (107) rotates the dose setting element (22) to one end of the spring (40) during dose setting, and disengages the dose setting element (22) from one end of the spring (40) during dose administration. The further clutch (107) has further first engaging portions (110, 565) and further second engaging portions (108, 566, 651), Further first engaging portions (110, 565) move to engage with further second engaging portions (108, 566, 651), thereby rotatably locking the dose setting element (22) to one end of the spring (40). At least one mechanism of a prior embodiment (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0574] 110. One of the further first engaging portion (110, 565) and further second engaging portion (108, 566, 651) is fixed to the button (318) in the rotational and axial directions. At least the mechanism of Embodiment 109 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0575] 111. One of the further first engaging portion (110, 565) and the further second engaging portion (108, 566, 651) is fixed to the dose setting element (22) in the rotational and axial directions. At least one mechanism from embodiments 109 and 110 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0576] 112. The dose setting element (22) is coupled to a further clutch (107) via a button (318). At least one mechanism from embodiments 109 to 111 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0577] 113. A further clutch (107) acts between the drug delivery member (323, 670) and the dose setting element (22). At least one mechanism from embodiments 109 to 112 and at least one mechanism from embodiments 9 to 17 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0578] 114. One of the further first engaging portion (110, 565) and the further second engaging portion (108, 566, 651) is fixed to the drug dispensing member (323, 670) in the rotational direction. At least the mechanism of Embodiment 113 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0579] 115. One of the further first engaging portion (110, 565) and the further second engaging portion (108, 566, 651) is fixed axially to the drug dispensing member (323, 670). At least the mechanism of Embodiment 114 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0580] 116. Further clutches (107) are located within the drug delivery members (323, 670). At least one mechanism from embodiments 113 to 115 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0581] 117. The clutch (113) includes a first engaging portion (114, 561) that engages with a second engaging portion (108, 562, 651) to secure a nut (38) to the piston rod (44) in the rotational direction during dose administration. The second engaging portion (108, 562, 651) of the clutch (113) forms a further second engaging portion (108, 566, 651) of a further clutch (107). At least one mechanism from embodiments 104 to 108 and at least one mechanism from embodiments 109 to 116 (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0582] 118. The nut (38) is screw-connected to the piston rod (44), such as by screw-engaging with the piston rod (44). At least one mechanism of a prior embodiment (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0583] 119. When the mechanism (354, 610, 620, 630, 640, 650, 660, 700, 800) is in the dose setting state, the nut (38) is movable in the rotational direction relative to the piston rod (44). When the mechanism (354, 610, 620, 630, 640, 650, 660, 700, 800) is in a dose-administering state, the nut (38) is fixed to the piston rod (44) in the rotational direction. At least one mechanism of a prior embodiment (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0584] 120. When the mechanism (354, 610, 620, 630, 640, 650, 660, 700, 800) is in the dose setting state, the nut (38) is movable axially with respect to the piston rod (44). When the mechanism (354, 610, 620, 630, 640, 650, 660, 700, 800) is in a dose-administering state, the nut (38) is fixed axially to the piston rod (44). At least one mechanism of a prior embodiment (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0585] 121. The rotation of the dose setting element (22) during dose setting is limited to less than one rotation. At least one mechanism of a prior embodiment (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0586] 122. The spring (40) is configured as a torsion spring (40). At least one mechanism of a prior embodiment (354, 610, 620, 630, 640, 650, 660, 700, 800).

[0587] 123. A drug delivery device (300) comprising at least one mechanism (354, 610, 620, 630, 640, 650, 660, 700, 800) of a prior embodiment.

[0588] Further embodiments of the mechanism and drug delivery device described herein include the following: 1. Mechanisms (354, 610, 620, 630, 640) for an automated drug dispensing device (300), Housing (332) and, Dose setting element (22), Button (318), A piston rod (44) is fixed to the housing (332) in the rotational direction and movable in the axial direction, Nut (38) and, Spring (40) and, Equipped with, The dose setting element (22) is configured to be grasped by the user of the device in order to set the dose to be administered by rotating the dose setting element (22) relative to the housing (332) when the mechanism (354, 610, 620, 630, 640) is in the dose setting state. The rotation of the dose setting element (22) stores energy in the spring (40), The rotation of the dose setting element (22) moves the nut (38) proximal to the piston rod (44) by a dose distance (3), and the dose distance (3) is proportional to the dose. The mechanism (354, 610, 620, 630, 640) is configured such that when the button (318) is moved relative to the housing (332), it switches from the dose setting state to the dose administration state. The transition to the dose-administration state is caused by connecting the spring (40) to the nut (38) and releasing the energy accumulated during dose setting, thereby causing the nut (38) to move automatically in the proximal direction (1). The piston rod (44) is configured to move proximal (1) by a dose distance (3) together with the nut (38) when the mechanism (354, 610, 620, 630, 640) is in a dose-administering state, in order to administer the dose. The dose setting element (22) is configured to remain stationary axially relative to the housing (332) when the piston rod (44) moves proximal (1) to administer a dose. mechanism.

[0589] 2. Further comprising a drug delivery member (323), The drug dispensing member (323) is configured to rotate relative to the housing (332) during dose setting and during dose administration. The drug delivery member (323) is configured to remain stationary in the axial direction relative to the housing (332) during dose administration. Mechanism of Embodiment 1 (354, 610, 620, 630, 640).

[0590] 3. The drug dispensing member (323) is configured to remain axially stationary relative to the housing (332) while energy is being stored in the spring (40) during dose setting. Mechanism of Embodiment 2 (354, 610, 620, 630, 640).

[0591] 4. The drug dispensing member (323) is coupled between the spring (40) and the dose setting element (22) during dose setting, and transmits energy from the dose setting element (22) to the spring (40). At least one mechanism of Embodiments 2 and 3 (354, 610, 620, 630, 640).

[0592] 5. The medication dispensing component (323) includes a label (168) that visually indicates the dosage setting. At least one mechanism (354, 610, 620, 630, 640) of Embodiments 2 to 4.

[0593] 6. Further equipped with Blocker (430), The blocker (430) acts between the button (318) and the housing (332), The blocker (430) prevents the button (318) from moving axially distal to the housing (332). At least one mechanism of a prior embodiment (354, 610, 620, 630, 640).

[0594] 7. The blocker (430) acts between the drug delivery member (323) and the housing (332), For example, the blocker (430) is provided on one of the housing (332) and the drug dispensing member (323) and engages with the other of the housing (332) and the drug dispensing member (323). At least one mechanism from Embodiment 6 and Embodiments 2-5 (354, 610, 620, 630, 640).

[0595] 8. The blocker (430) is configured as a one-way blocker (430), The blocker (430) allows relative axial movement between the housing (332) and the counter element (116) in a first direction, and prevents relative axial movement between the housing (332) and the counter element (116) in a second direction opposite to the first direction. At least the mechanisms of embodiments 6 and 7 (354, 610, 620, 630, 640).

[0596] 9. The blocker (430) is configured as a flexible element that snaps into a blocking position when the counter element (116) is assembled to the housing (332). Mechanism of Embodiment 8 (354, 610, 620, 630, 640).

[0597] 10. The counter element (116) is part of the drug dispensing member (323). At least one of embodiments 8 and 9, and at least one mechanism from embodiments 2 to 5 (354, 610, 620, 630, 640).

[0598] 11. The mechanism (354, 610, 620, 630, 640) includes stoppers (373, 374) for restricting the proximal movement of the button (318) during dose administration. At least one mechanism of a prior embodiment (354, 610, 620, 630, 640).

[0599] 12. The drug dispensing member (323) is coupled between the stopper (374) and the housing (332). At least one mechanism from Embodiment 11 and Embodiments 2 to 5 (354, 610, 620, 630, 640).

[0600] 13. The stopper (373) is provided to the housing (332), such as the inner surface (371) of the housing (332). Mechanism of Embodiment 11 (354, 610, 620, 630, 640).

[0601] 14. The stopper (373) acts between the housing (332) and the housing connector (360) which is fixed axially to the button (318). Mechanism of Embodiment 13 (354, 610, 620, 630, 640).

[0602] 15. The stopping parts (373, 374) are configured as axial stopping parts. At least one mechanism (354, 610, 620, 630, 640) of embodiments 11 to 14.

[0603] Additional embodiments of the mechanism and drug delivery device described herein include the following: 1. Mechanisms (354, 610, 620, 630, 640, 650) for an automated drug dispensing device (300), Housing (332) and, Dose setting element (22), Button (318), A piston rod (44) is fixed to the housing (332) in the rotational direction and movable in the axial direction, Nut (38) and, Spring (40) and, Equipped with, The dose setting element (22) is configured to be grasped by the user of the device in order to set the dose to be administered by rotating the dose setting element (22) relative to the housing (332) when the mechanism (354, 610, 620, 630, 640, 650) is in the dose setting state. The rotation of the dose setting element (22) stores energy in the spring (40), The rotation of the dose setting element (22) moves the nut (38) proximal to the piston rod (44) by a dose distance (3), and the dose distance (3) is proportional to the dose. The mechanism (354, 610, 620, 630, 640, 650) is configured such that when the button (318) is moved relative to the housing (332), it switches from the dose setting state to the dose administration state. The transition to the dose-administration state is caused by connecting the spring (40) to the nut (38) and releasing the energy accumulated during dose setting, thereby causing the nut (38) to move automatically in the proximal direction (1). The piston rod (44) is configured to move proximal (1) by a dose distance (3) together with the nut (38) when the mechanism (354, 610, 620, 630, 640, 650) is in the dose-administering state, thereby administering the dose. The dose setting element (22) and the button (318) are movable relative to each other. mechanism.

[0604] 2. The button (318) is movable axially relative to the dose setting element (22), and the button (318) is fixed rotationally relative to the dose setting element (22). Mechanism of Embodiment 1 (354, 610, 620, 630, 640, 650).

[0605] 3. The dose setting element (22) is fixed axially to the housing (332) during dose setting and dose administration. At least one mechanism of a prior embodiment (354, 610, 620, 630, 640, 650).

[0606] 4. Further comprising a drug delivery member (323), The drug dispensing member (323) is configured to rotate relative to the housing (332) during dose setting and during dose administration. The rotational position of the drug dispensing member (323) defines the dosage. At least one mechanism of a prior embodiment (354, 610, 620, 630, 640, 650).

[0607] 5. The drug delivery member (323) includes a first part (24) and a second part (334), The first part (24) is movable axially relative to the second part (334) and fixed in the rotational direction. At least the mechanism of Embodiment 4 (354, 610, 620, 630, 640, 650).

[0608] 6. The first part (24) includes one of the dose-stopping parts (118, 119) and counter elements (116) of the dose-defining mechanism (115), and / or The second part (334) includes a label that visually indicates the dosage setting. At least the mechanism of Embodiment 5 (354, 610, 620, 630, 640, 650).

[0609] 7. Further includes a dose-defining mechanism (115), The dose-defining mechanism (115) acts between the dose-setting element (22) and the housing (332) during dose setting. The dose-defining mechanism (115) has at least one dose-stopping unit (118, 119) and a counter element (116), The counter element (116) is configured to rotate relative to the dose stop unit (118, 119) when the dose setting element (22) rotates during dose setting. The counter element (116) is configured to engage with the dose stop unit (118, 119) when the dose is set. One of the dose stop units (118, 119) and the counter element (116) is fixed axially to the button (318), and the other of the dose stop units (118, 119) and the counter element (116) is fixed axially to the housing (332). At least one mechanism of a prior embodiment (354, 610, 620, 630, 640, 650).

[0610] 8. One of the dose-stopping units (118, 119) and the counter element (116) is located radially inward from the other of the dose-stopping units (118, 119) and the counter element (116). At least the mechanism of Embodiment 7 (354, 610, 620, 630, 640, 650).

[0611] 9. One of the dose stop units (118, 119) and the counter element (116) is rotatably movable relative to the housing (332), for example, the other of the dose stop units (118, 119) and the counter element (116) is fixed rotatably relative to the housing (332). At least the mechanisms of embodiments 7 and 8 (354, 610, 620, 630, 640, 650).

[0612] 10. One of the dose stop units (118, 119) and the counter element (116) is fixed to the housing (332) in the rotational direction, and the other of the dose stop units (118, 119) and the counter element (116) is movable to the housing (332) in the rotational direction. At least the mechanism of Embodiment 7 (354, 610, 620, 630, 640, 650).

[0613] 11. One of the dose stop units (118, 119) and counter elements (116) is fixed to the dose selector (550). The dose selector (550) is axially movable and is rotatably fixed to the housing (332). The dose selector (550) is located entirely within the mechanism (354, 610, 620, 630, 640, 650). At least the mechanism of Embodiment 10 (354, 610, 620, 630, 640, 650).

[0614] 12. Further including the clutch (113), The clutch (113) rotates the nut (38) onto the piston rod (44) during dose administration, and rotates the nut (38) away from the piston rod (44) during dose setting. The clutch (113) has a first engaging portion (114, 561) fixed to the housing (332) in the rotational direction, and a second engaging portion (108, 562, 651) fixed to the button (318) in the rotational direction. The first engaging portion (114, 561) is fixed axially to the housing (332). At least one mechanism of a prior embodiment (354, 610, 620, 630, 640, 650).

[0615] 13. Including additional clutches (107), A further clutch (107) rotates the dose setting element (22) to one end of the spring (40) during dose setting, and disengages the dose setting element (22) from one end of the spring (40) during dose administration. The further clutch (107) has further first engaging portions (110, 565) and further second engaging portions (108, 566, 651), Further first engaging portions (110, 565) move to engage with further second engaging portions (108, 566, 651), thereby rotatably locking the dose setting element (22) to one end of the spring (40). One of the further first engaging portion (110, 565) and the further second engaging portion (108, 566, 651) is fixed to the dose setting element (22) in the rotational and axial directions, and is movable in the rotational and axial directions relative to the button (318). At least one mechanism of a prior embodiment (354, 610, 620, 630, 640, 650).

[0616] 14. A further clutch (107) is located within the drug delivery member (323). At least one mechanism from Embodiment 13 and Embodiments 4-6 (354, 610, 620, 630, 640, 650).

[0617] 15. A drug delivery device (300) comprising at least one mechanism (354, 610, 620, 630, 640, 650) of a prior embodiment.

Claims

1. A mechanism (354, 610, 620, 630, 640, 650, 660, 700, 800) for an automated drug dispensing device (300), Housing (332) and Dose setting element (22), Button (318) and A piston rod (44) is fixed to the housing (332) in the rotational direction and movable in the axial direction, Nut (38) and Spring (40) and Equipped with, The dose setting element (22) is configured to be grasped by the user of the device in order to set the dose to be administered by rotating the dose setting element (22) relative to the housing (332) when the mechanism (354, 610, 620, 630, 640, 650, 660, 700, 800) is in the dose setting state. The rotation of the dose setting element (22) stores energy in the spring (40), The rotation of the dose setting element (22) moves the nut (38) proximal to the piston rod (44) by a dose distance (3), and the dose distance (3) is proportional to the dose. The aforementioned mechanism (354, 610, 620, 630, 640, 650, 660, 700, 800) is configured such that when the button (318) is moved relative to the housing (332), it switches from the dose setting state to the dose administration state. The spring (40) is coupled to the nut (38) in the dose-administering state and releases the energy accumulated during dose setting, causing the nut (38) to move automatically in the proximal direction (1). The piston rod (44) is configured to move together with the nut (38) by the dose distance (3) in the proximal direction (1) when the mechanism (354, 610, 620, 630, 640, 650, 660, 700, 800) is in the dose-administering state, to administer the dose. The button (318) is configured to remain stationary in the axial direction relative to the housing (332) when the piston rod (44) moves in the proximal direction (1) to administer the dose. Mechanism (354, 610, 620, 630, 640, 650, 660, 700, 800).

2. Further comprising a drug delivery member (323), The drug dispensing member (323) is configured to rotate relative to the housing (332) during dose setting and during dose administration. The drug delivery member (323) is configured to remain stationary in the axial direction relative to the housing (332) during dose administration. The mechanism described in claim 1 (354, 610, 620, 630, 640, 650, 660, 700, 800).

3. The drug dispensing member (323) is configured to remain stationary in the axial direction relative to the housing (332) while the energy is being stored in the spring (40) during dose setting. The mechanism described in claim 2 (354, 610, 620, 630, 640, 650, 660, 700, 800).

4. The drug dispensing member (323) is configured to remain stationary in the axial direction relative to the housing (332) when the mechanism (354, 610, 620, 630, 640, 650, 660, 700, 800) transitions from a dose setting state to a dose administration state. The mechanism according to at least one of claims 2 and 3 (354, 610, 620, 630, 640, 650, 660, 700, 800).

5. The drug dispensing member (323) is coupled between the spring (40) and the dose setting element (22) during dose setting, and transmits the energy from the dose setting element (22) to the spring (40). The mechanism according to at least one of claims 2 and 4 (354, 610, 620, 630, 640, 650, 660, 700, 800).

6. The drug dispensing member (323) is axially movable with respect to the drug dispensing elements (334, 681, 740, 830) which include a marker (168) that visually indicates the setting of the dose. The mechanism according to at least one of claims 2 to 5 (354, 610, 620, 630, 640, 650, 660, 700, 800).

7. The device further includes a blocker (752) and a biasing element (250), The blocker (752) restricts the axial movement of the drug delivery element (323) in the proximal direction (1), The biasing element (250) is configured to bias the drug delivery element (323) in the proximal direction (1) relative to the blocker (752). The mechanism according to at least one of claims 2 to 6 (354, 610, 620, 630, 640, 650, 660, 700, 800).

8. The biasing element (250) acts between the medication element (323) and the button (318). At least the mechanism described in claim 7 (354, 610, 620, 630, 640, 650, 660, 700, 800).

9. It also includes drivers (336, 660, 720, 820), The drivers (336, 660, 720, 820) are coupled between the spring (40) and the nut (38) when the mechanism (354, 610, 620, 630, 640, 650, 660, 700, 800) is in the dose-administering state, and transmit the energy stored in the spring (40) to the nut (38). For example, the drivers (336, 660, 720, 820) are configured to move distally when the mechanism (354, 610, 620, 630, 640, 650, 660, 700, 800) is in the dose setting state, and to move proximal (1) when the mechanism (354, 610, 620, 630, 640, 650, 660, 700, 800) is in the dose administration state. The mechanism according to at least one of claims 1 to 8 (354, 610, 620, 630, 640, 650, 660, 700, 800).

10. The drivers (336, 660, 720, 820) are rotatably fixed to a medication element (334, 671, 740, 830) that indicates to the user a dose set by a marker (168) visible through, for example, a window (166) of the housing (332). At least the mechanism described in claim 9 (354, 610, 620, 630, 640, 650, 660, 700, 800).

11. The drivers (336, 660, 720, 820) are fixed axially to the drug dispensing elements (334, 671, 740, 830). At least the mechanism described in claim 10 (354, 610, 620, 630, 640, 650, 660, 700, 800).

12. The drivers (336, 660, 720, 820) are axially movable relative to the drug dispensing elements (334, 671, 740, 830). At least the mechanism described in claim 10 (354, 610, 620, 630, 640, 650, 660, 700, 800).

13. The drug delivery elements (334, 671, 740, 830) are screw-connected to the housing (323). At least the mechanism described in claim 12 (354, 610, 620, 630, 640, 650, 660, 700, 800).

14. The drug delivery element (830) is driven by the driver (820) during dose setting. The mechanism according to at least one of claims 10 to 13 (354, 610, 620, 630, 640, 650, 660, 700, 800).

15. The mechanism (354, 610, 620, 630, 640, 650, 660, 700, 800) includes stoppers (373, 374) for restricting the proximal movement of the button (318) during dose administration. The stopper (373) is provided on the inner surface (371) of the housing (332), etc. The mechanism according to at least one of claims 1 to 14 (354, 610, 620, 630, 640, 650, 660, 700, 800).

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